Biological
Main information
- Trade name:
- Biological stain IVDs
- Available from:
- Elitechgroup Australia Pty Ltd
- Class:
- - IVD Class 2
- Medicine domain:
- Humans
- Medicine type:
- Medical device
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 217558
- Last update:
- 09-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
217558
Elitechgroup Australia PTY LTD - Biological stain IVDs
ARTG entry for
Medical Device Included - IVD Class 2
Sponsor
Elitechgroup Australia Pty Ltd
Postal Address
PO Box 576,BRAESIDE, VIC, 3195
Australia
ARTG Start Date
20/11/2013
Product category
Medical Device Class 2
Status
Active
Approval area
Conditions
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Manufacturers
Name
Address
Kova International
7272 Chapman Avenue
Garden Grove, CA, 92841
United States Of America
Products
1. Biological stain IVDs
Product Type
Effective date
20/11/2013
GMDN
CT215 Biological stain IVDs
Intended purpose
Dyes, chemicals, stains or solutions intended to be used specifically as an IVD, either alone or in
combination with others, for the visualisation of structures and/or other intra/extracellular elements in
biological tissues.
Specific Conditions
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Public Summary
Page 1 of
Produced at 10.11.2017 at 01:54:25 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
Documents in other languages are available here
- Access to this document is only available to registered users.
Register now for full access
31-1-2019

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information derived from the year 2018
Published on: Wed, 30 Jan 2019 This reporting manual provides guidance to Member States (MSs) for reporting on zoonoses and zoonotic agents in animals, food and feed under the framework of Directive 2003/99/EC and also on the reporting of other pathogenic microbiological agents in food. The objective of this manual is to harmonise and streamline reporting by MSs to ensure that the data collected are relevant and comparable for analysis at the European Union (EU) level. This manual covers all the zoonose...
Europe - EFSA - European Food Safety Authority EFSA Journal
26-1-2019

Overview of available toxicity data for calystegines
Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...
Europe - EFSA - European Food Safety Authority EFSA Journal
25-1-2019

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018
Published on: Thu, 24 Jan 2019 The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain lev...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-12-2018

Pest categorisation of Phyllosticta solitaria
Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...
Europe - EFSA - European Food Safety Authority EFSA Journal
19-12-2018

Pest categorisation of Grapholita prunivora
Published on: Tue, 18 Dec 2018 The European Commission requested EFSA to conduct a pest categorisation of Grapholita prunivora (Lepidoptera: Tortricidae), an oligophagous moth whose larvae feed mostly on leaves and fruit of different Rosaceae including cultivated apples, plums, cherries and pecans. It overwinters in soil and bark crevices of its host plants. G. prunivora has reliable identification methods, both for adults and immature stages. It occurs in North America, where it can impact pome and sto...
Europe - EFSA - European Food Safety Authority EFSA Journal
15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018
Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...
Europe - EFSA - European Food Safety Authority Publications
13-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
FDA - U.S. Food and Drug Administration
13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts
Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...
Europe - EFSA - European Food Safety Authority Publications
8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion
Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...
Europe - EFSA - European Food Safety Authority Publications
12-9-2018

Application of data science in risk assessment and early warning
Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...
Europe - EFSA - European Food Safety Authority Publications
11-9-2018

Risk ranking of chemical and microbiological hazards in food
Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...
Europe - EFSA - European Food Safety Authority Publications
11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)
Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...
Europe - EFSA - European Food Safety Authority Publications
11-9-2018

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants
Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...
Europe - EFSA - European Food Safety Authority Publications
8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination
Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.
FDA - U.S. Food and Drug Administration
31-7-2018

ANSES Collective expert appraisal: summary of discussion with conclusions regarding the expert appraisal for recommending occupational exposure limits for chemical agents: On the evaluation of biomarkers of exposure and recommendation for biological limit
France - Agence Nationale du Médicament Vétérinaire
31-7-2018

ANSES Collective expert appraisal: summary of discussion with conclusions regarding the “expert appraisal on recommending occupational exposure limits for chemical agents”: Evaluation of biomarkers and recommendations for biological limit values and biolo
France - Agence Nationale du Médicament Vétérinaire
23-7-2018

Scientific guideline: Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins - Revision 1, adopted
Europe - EFSA - European Food Safety Authority EFSA Journal
20-7-2018

Scientific guideline: Annex to Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Guideline on similar medicinal products containing somatropin - Rev. 1, ad
Europe - EFSA - European Food Safety Authority EFSA Journal
4-2-2016

Updated list of biological medicinal products
The Danish Medicines Agency has added five new medicinal products to the list of biological and biosimilar medicinal products.
Danish Medicines Agency
10-9-2015

Christian Schneider appointed new NIBSC director
Christian Schneider, Medical Head of Division, has been appointed new director of the National Institute for Biological Standards and Control (NIBSC), which is located north of London, England.
Danish Medicines Agency
25-1-2019

Infanrix hexa (GlaxoSmithKline Biologicals S.A.)
Infanrix hexa (Active substance: diphtheria (d), tetanus (t), pertussis (acellular, component) (pa), hepatitis b (rdna) (hbv), poliomyelitis (inactivated) (ipv) and haemophilus influenzae type b (hib) conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2019)676 of Fri, 25 Jan 2019
Europe -DG Health and Food Safety
12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018
TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98
Therapeutic Goods Administration - Australia
29-10-2018

Synflorix (GlaxoSmithKline Biologicals S.A.)
Synflorix (Active substance: Pneumococcal polysaccharide conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)7257 of Mon, 29 Oct 2018
Europe -DG Health and Food Safety
12-9-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018
This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...
Europe - EMA - European Medicines Agency
15-8-2018

Scientific guideline: Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1, draft: consultation open
The proposed guideline will replace annex to guideline on similar medicinal products containing biotechnology-derived proteins as active substance: Non-Clinical and Clinical Issues - Guidance on similar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA/CHMP/BMWP/31329/2005
Europe - EMA - European Medicines Agency
27-7-2018

Australian regulatory guidelines for biologicals (ARGB)
The ARGB has been restructured and updated in line with new legislative changes
Therapeutic Goods Administration - Australia
27-7-2018

General dossier requirements
Amendments to Part C to update the reference for dossier requirements for biologicals
Therapeutic Goods Administration - Australia
27-6-2018

Regulatory and procedural guideline: European Specialist Nurses Organisations (ESNO) - Switch management between similar biological medicines: A communication information guide for nurses (draft), draft
Europe - EMA - European Medicines Agency
3-5-2018

ARGB is being restructured for publication in July 2018
In preparation for the restructure of the ARGB in July, we have restructured some of the biologicals sections of the TGA website
Therapeutic Goods Administration - Australia
20-4-2018

Biologicals regulatory framework proposed changes to start on 1 July 2018
We are proposing changes to the Biologicals Regulatory Framework, including changes to autologous cell and tissue product regulation
Therapeutic Goods Administration - Australia