Panels › Microbiology › Product code MZP · Class 2
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation 866.3170
1510(k)s in 12 months (4 all time)
0recalls in 12 months (11 all time)
0recalls that name a 510(k)
Top companies in MZP
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Molecular, Inc. | 1 | 6 |
| Roche Molecular Systems, Inc. | 2 | 5 |
| Hologic, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2023 | Abbott Molecular, Inc. Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automa Open, Classified |
MZP | None listed |
| Jul 19, 2022 | Abbott Molecular, Inc. The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. Completed |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Terminated |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Terminated |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Open, Classified |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Open, Classified |
MZP | None listed |
| Jun 17, 2011 | Roche Molecular Systems, Inc. COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD
The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human p Terminated |
MZP | None listed |
| Jun 17, 2011 | Roche Molecular Systems, Inc. COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD
The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human p Terminated |
MZP | None listed |
| Aug 2, 2007 | Roche Molecular Systems, Inc. Amplilink Software Versions 1.1, 1.3, 1.4, 2.41
COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0 Terminated |
MZP | None listed |
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.
Kit: AmpliCap HCV MonitorTest, Export, RUO. Terminated |
MZP | None listed |
| Aug 19, 2004 | Roche Molecular Systems Inc Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.)
Kit: Amplicor HCV Detection Kit, v2.0 Terminated |
MZP | None listed |
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