RealTime

FDA UDI

ABBOTT MOLECULAR INC.·00884999000728·Abbott RealTime HCV Amplification Reagent Kit

RealTime

FDA UDI

ABBOTT MOLECULAR INC.·00884999042513·Abbott RealTime HCV Genotype II m2000 System Co...

cobas 6800 System

FDA UDI

Roche Diagnostics GmbH·04015630935406·

Aptima®

FDA UDI

Hologic, Inc.·15420045506794·Aptima® HCV Quant Dx Assay Controls Kit.

Aptima®

FDA UDI

Hologic, Inc.·15420045506800·Aptima® HCV Quant Dx Assay Calibrator.

VERSANT HCV 2.0 LiPA

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414000503·VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Te...

Aptima®

FDA UDI

Hologic, Inc.·15420045506787·The Aptima® HCV Quant Dx assay is a real-time t...

VERSANT HCV Control 2.0 Kit (LiPA)

FDA UDI

Siemens Healthcare Diagnostics Inc.·00630414000510·VERSANT HCV Control 2.0 Kit

Aptima

FDA UDI

Hologic, Inc.·15420045500235·

ABBOTT MOLECULAR, INC.

FDA registration

ABBOTT MOLECULAR, INC.·2 products·🇺🇸 United States

cobas HCV

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima HCV Quant Dx Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m

FDA UDI

ABBOTT MOLECULAR INC.·00884999050860·Alinity m HCV Application Specification File

RealTime

FDA UDI

ABBOTT MOLECULAR INC.·00884999037472·Uracil-N-Glycosylase (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Genotyping, Hepatitis C Virus

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification

FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·cobas HCV Test