PMA P050042S002

Device: ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S002
Product code: MZO
Decision date: 2007-03-05
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Approval order statement: APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).

Current openFDA PMA Record#

Device: ARCHITECT ANTI-HCV
Applicant: Abbott Laboratories, Inc.
PMA number: P050042
Supplement: S002
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2007-03-05
Decision code: APPR
Date received: 2007-01-11
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXTEND THE EXPIRATION DATING OF REAGENTS, CALIBRATORS, AND CONTROLS TO 14 MONTHS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ARCHITECT ANTI-HCV AND IS INDICATED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN G (IGG) AND IMMUNOGLOBULIN M (IGM) ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, AND SODIUM HEPARIN).