Beckman Coulter SYNCHRON System(s) Opiate 300 ng (OP)

Singapore - English - HSA (Health Sciences Authority)

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Available from:
BECKMAN COULTER SINGAPORE PTE. LTD.
Class:
Class B IVD
Manufactured by:
Beckman Coulter Inc
Therapeutic area:
Clinical toxicology
Therapeutic indications:
Opiate 300 Ng reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s) and SYNCHRON® Systems OP 300 Urine Calibrators, is intended for the qualitative determination of opiates in human urine at a cutoff value of 300 ng/mL (morphine).
Product summary:
Device System Info:[Device with measuring function], [System or Procedure Pack], IVD system with analyzer; Models: SYNCHRON® System(s) Opiate 300 ng (OP) - 475024, SYNCHRON Systems DAT Negative Urine Calibrator - 445803, SYNCHRON Systems OP 300 Low Urine Calibrator - 474982, SYNCHRON Systems OP 300 High Urine Calibrator - 474985, SYNCHRON Systems OP 300 Low Urine Control - 474988, SYNCHRON Systems OP 300 High Urine Control - 474991, SYNCHRON Systems DAT Drug Free Control - 469945, UniCel DxC 600 PRO, Packaged - A10400, UniCel DxC 600, Packaged - A10405, UniCel DxC 800 PRO, Packaged - A10407, UniCel DxC 800, Packaged - A10411, UniCel DxC 600, Crated - A16737, UniCel DxC 600 PRO, Crated - A16738, UniCel DxC 800, Crated - A16739, UniCel DxC 800 PRO, Crated - A16740, Packaged System - DxC 800 AR - A80377, Crated System - DxC 800 AR - A80378, DxC 600 AR Packaged System - A82112, DxC 600 AR Crated System - A82113
Authorization number:
DE0016567
Authorization date:
2014-11-24

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