Product Code: MZP


Products Classified as MZP

3606Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

Total Product Life Cycle (TPLC) Devices

3606Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus

FDA Consensus Standards

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus [30536]21 CFR Unclassified 🔎
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus [30535]21 CFR Unclassified 🔎

Pre-market Approvals for MZP

P100017Abbott RealTime HCV AssayABBOTT MOLECULAR, INC.
P060030COBAS AmpliPrep/COBAS TaqMan HCV TestRoche Molecular Systems, Inc.
P150015cobas HCVRoche Molecular Systems, Inc.
P160023Aptima HCV Quant Dx AssayHOLOGIC, INC.
P020011Aptima HCV RNA Qualitative AssayGEN-PROBE

Pre-market Notifications for MZP

K221007Cobas HCVRoche Molecular Systems, Inc.

Global Unique Device Identification Database

00630414472393Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
00630414472386Assay,Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
00884999042681ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999037656ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999037472ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999037434ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999000728ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999000711ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999000704ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00884999000698ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00875197005127ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00875197004748ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00875197004694ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00875197004502ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS
00875197004496ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS

Maude Adverse Events

COBAS MPX TEST, CE-IVDROCHE MOLECULAR SYSTEMS, INC.2020-02-25
COBAS TAQSCREEN MPX TEST, V2.0ROCHE MOLECULAR SYSTEMS, INC.2019-07-12
COBAS TAQSCREEN MPX TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2019-06-28
COBAS MPX TEST, CE-IVDROCHE MOLECULAR SYSTEMS, INC.2019-05-22
COBAS TAQSCREEN MPX TEST V2ROCHE MOLECULAR SYSTEMS2019-04-11
COBAS TAQSCREEN MPX TEST, V2.0ROCHE MOLECULAR SYSTEMS, INC.2019-03-20
COBAS MPX TEST, CE-IVDROCHE MOLECULAR SYSTEMS, INC.2018-10-23
ABBOTT REALTIME HCV AMPLIFICATION REAGENT KITABBOTT MOLECULAR, INC.2018-05-24
ABBOTT REALTIME HCV AMPLIFICATION REAGENT KITABBOTT MOLECULAR, INC.2018-05-24
COBAS TAQSCREEN MPX TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2018-05-11
COBAS E 411 IMMUNOASSAY ANALYZERROCHE DIAGNOSTICS2018-01-10
COBAS TAQSCREEN MPX TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS, INC.2017-11-15
COBAS TAQSCREEN MPX TEST, VERSION 2.0ROCHE MOLECULAR SYSTEMS, INC.2017-05-03
COBAS TAQSCREEN MPX TEST, VERSION 2.0ROCHE MOLECULAR SYSTEMS, INC.2017-05-03
COBAS TAQSCREEN MPX TEST, VERSION 2.0ROCHE MOLECULAR SYSTEMS, INC.2017-05-03
COBAS TAQSCREEN MPX TEST, VERSION 2.0ROCHE MOLECULAR SYSTEMS, INC.2017-05-03
COBAS TAQSCREEN MPX TEST V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2017-04-11
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST, V2.0ROCHE MOLECULAR SYSTEMS2017-02-09
COBAS? TAQSCREEN MPX TEST, VERSION 2.0 CE-IVD TESTROCHE MOLECULAR SYSTEMS2017-01-11
COBAS HCV TESTROCHE MOLECULAR SYSTEMS2016-08-10
CAP/CTM HCV TEST, V2.0ROCHE MOLECULAR SYSTEMS2016-08-08
CAP/CTM HCV TEST, V2.0ROCHE MOLECULAR SYSTEMS2016-08-03
CAP/CTM HCV TEST, V2.0ROCHE MOLECULAR SYSTEMS2016-08-03
CAP/CTM HCV TEST, V2.0ROCHE MOLECULAR SYSTEMS2016-08-03
KIT CAP/CTM HCV V2.0 72T US-IVDROCHE MOLECULAR SYSTEMS2016-05-27
KIT CAP/CTM HCV V2.0 72T US-IVDROCHE MOLECULAR SYSTEMS2016-05-27
COBAS TAQSCREEN MPX TEST, V2 US-IVDROCHE MOLECULAR SYSTEMS, INC2016-01-28
COBAS TAQSCREEN MPX TEST V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2016-01-15
COBAS TAQSCREEN MPX TEST, V2.0, CE-IVDROCHE MOLECULAR SYSTEMS2016-01-08
COBAS TAQSCREEN MPX TEST, V2.0, CE-IVDROCHE MOLECULAR SYSTEMS2016-01-08
COBAS TAQSCREEN MPX TEST, V2.0, CE-IVDROCHE MOLECULAR SYSTEMS2016-01-08
PRISM 6 CHANNEL ANALYZERABBOTT MANUFACTURING INC2015-05-04
COBAS TAQSCREEN MPX TESTROCHE MOLECULAR SYSTEMS2014-11-03
PRISM 6 CHANNEL ANALYZERABBOTT MANUFACTURING INC2014-09-29
ARCHITECT I2000SR ANALYZERABBOTT MANUFACTURING INC2014-06-26
CAP-CTM HCV QUANT TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2014-05-13
COBAS TAQSCREEN MPX TEST CE-IVDROCHE MOLECULAR SYSTEMS2014-04-11
COBAS TAQSCREEN MPX TEST CE-IVDROCHE MOLECULAR SYSTEMS2014-04-11
COBAS TAQSCREEN MPX TEST CE-IVDROCHE MOLECULAR SYSTEMS2014-04-11
COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVDROCHE MOLECULAR SYSTEMS2014-03-28
COBAS TAQMAN HCV TEST, V2.0 FOR USE WITH THE HIGH PURE SYSTEM CE-IVDROCHE MOLECULAR SYSTEMS2014-03-28
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2014-03-27
CAP-CTM HCV QUANT TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2014-03-20
COBAS AMPLIPREP / COBAS AMPLICOR HCV TEST, V2.0 CE-IVDROCHE MOLECULAR SYSTEMS2014-03-19
COBAS 6000 E601 MODULEROCHE DIAGNOSTICS2014-02-11
CAP CTM HCV TESTROCHE MOLECULAR SYSTEMS2013-12-19
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-12-17
ADVIA CENTAUR XPSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-11-25
KIT CAP-G/CTM HCV 48 TESTS VERSION 1ROCHE MOLECULAR SYSTEMS2013-11-20
ADVIA CENTAURSIEMENS HEALTHCARE DIAGNOSTICS INC.2013-11-20

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