Beckman Coulter SYNCHRON System(s) Barbiturates (BARB)

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:
BARB reagent, in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for thequalitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL.
Product summary:
Device System Info:[Device with measuring function], [System or Procedure Pack], IVD system with analyzer; Models: SYNCHRON® System(s) Barbiturates (BARB) - 475012, SYNCHRON Systems DAT Negative Urine Calibrator (Cat. 445803) - 445803, SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator (Cat. 474970) - 474970, SYNCHRON Systems DAT Multi-Drug High Urine Calibrator (Cat. 474973) - 474973, SYNCHRON Systems DAT Multi-Drug Low Urine Control (Cat. 474976) - 474976, SYNCHRON Systems DAT Multi-Drug High Urine Control (474979) - 474979, 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:
DE0016550
Authorization date:
2014-11-18

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