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Miscellaneous
QGN
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
2
Product Code
PBK
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
2
Product Code
OBF
Assay, Genotyping, Hepatitis C Virus
3
Product Code
PGH
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
2
Product Code
QHM
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
U
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PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
2
Product Code
PRA
Variola Virus Nucleic Acid-Based Detection Assay
2
Product Code
PRH
Positive Blood Culture Identification And Ast Kit
2
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PVQ
Rickettsia Spp. Nucleic Acid Based Detection Assay
2
Product Code
PYN
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
2
Product Code
QAA
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
2
Product Code
QBD
Microbial Nucleic Acid Storage And Stabilization Device
2
Product Code
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
2
Product Code
QDZ
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
2
Product Code
QEP
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
2
Product Code
QFA
Assay For Detection Of Proteases In Chronic Wounds
2
Product Code
QFO
Zika Virus Serological Reagents
2
Product Code
QHO
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
U
Product Code
QID
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
2
Product Code
QNJ
Mass Spectrometry, Microorganism Identification, Blood Culture
2
Product Code
MZP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
3
Product Code
K
23
3352
Aptima HCV Quant Dx Assay
3
Cleared 510(K)
K
22
1007
cobas HCV
3
Cleared 510(K)
P
19
0025
Alinity m HCV
APPR
PMA Approval
P
16
0023
APTIMA HCV QUANT DX ASSAY
APPR
PMA Approval
P
15
0015
COBAS HCV TEST
APPR
PMA Approval
P
10
0017
ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
APPR
PMA Approval
P
06
0030
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
APPR
PMA Approval
P
02
0022
BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
APWD
PMA Approval
P
02
0011
VERSANT HCV RNA QUALITATIVE ASSAY
APPR
PMA Approval
P
00
0010
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
APWD
PMA Approval
Show All 11 Submissions
NCD
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
3
Product Code
NWY
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
N
Product Code
QPO
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
2
Product Code
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
2
Product Code
PZF
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
2
Product Code
QDS
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
2
Product Code
LOM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
3
Product Code
LQI
Hepatitis Delta Serological Reagents
3
Product Code
MAQ
Kit, Dna Detection, Human Papillomavirus
3
Product Code
MHR
Test, Anti-Tumor Cell Susceptibility
3
Product Code
MKT
Hepatitis Viral B Dna Detection
3
Product Code
MYL
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
3
Product Code
MYM
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
3
Product Code
MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
3
Product Code
OIH
Yersinia Spp. Reagents
U
Product Code
OJN
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
3
Product Code
OJO
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
N
Product Code
ORL
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
3
Product Code
OTT
Research Use Only/Microbiology
N
Product Code
OYB
Kit, Rna Detection, Human Papillomavirus
3
Product Code
PAB
Cytomegalovirus (Cmv) Dna Quantitative Assay
3
Product Code
PCY
Investigational Use Only - Microbiology
N
Product Code
POA
Reagents, Zika Virus Nucleic Acid
N
Product Code
POG
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
N
Product Code
PYS
Zika Virus Serological Reagents (Emergency Use)
N
Product Code
QHV
Multiple Osteoarticular Pathogen Antigen Kit
N
Product Code
QIM
Bartonella Spp. Serological Reagents
N
Product Code
QIN
Babesia Spp. Serological Reagents
N
Product Code
QIO
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
N
Product Code
QIP
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
N
Product Code
QIQ
Orientia Spp. (Scrub Typhus) Serological Reagents
N
Product Code
QJR
Reagents, 2019-Novel Coronavirus Nucleic Acid
N
Product Code
QKO
Reagent, Coronavirus Serological
N
Product Code
QKP
Coronavirus Antigen Detection Test System.
N
Product Code
QLT
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
N
Product Code
QLW
Covid-19 Test Home Collection Kit Devices
N
Product Code
QMN
Covid-19 Multi-Analyte Antigen Device
N
Product Code
QSH
Coronavirus Marker Detection
N
Product Code
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
2
Product Code
QSS
Hiv Self-Tests
3
Product Code
QTA
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
N
Product Code
QTP
Reagents, Monkeypox Virus Nucleic Acid.
N
Product Code
QTQ
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
N
Product Code
QWB
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
2
Product Code
QVR
Multiplex Nucleic Acid Detection System For Biothreat Agents
2
Product Code
QUU
Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
2
Product Code
QVF
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
2
Product Code
QVP
Sars-Cov-2 Serology Test
2
Product Code
QWR
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
2
Product Code
QXA
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
2
Product Code
QYA
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
2
Product Code
QYT
Over-The-Counter Covid-19 Antigen Test
2
Product Code
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
2
Product Code
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
2
Product Code
SBP
Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
2
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SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
2
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SBZ
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
2
Product Code
SCA
Multi-Analyte Respiratory Virus Antigen Detection Test
2
Product Code
SDM
Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
U
Product Code
SDN
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
U
Product Code
Submissions with No Product Code
Miscellaneous
Subpart B—Biological Stains
CFR Sub-Part
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Clinical Laboratory Instruments
CFR Sub-Part
Subpart C—Microbiology Devices
CFR Sub-Part
Subpart D—Serological Reagents
CFR Sub-Part
Subpart F—Immunological Test Systems
CFR Sub-Part
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
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Review Panel
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Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
MI
/
MI-misc
/
MZP
/
P150015
View Source
COBAS HCV TEST
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Roche Molecular Systems, Inc.
Trade Name
COBAS HCV TEST
Generic Name
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision Date
10/14/2015
Days to Decision
170 days
Decision Code
APPR
FDA Decision
Approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Miscellaneous
QGN
Lateral Flow Immunochromatography Assay For Host Infection Biomarkers
PBK
Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set
OBF
Assay, Genotyping, Hepatitis C Virus
PGH
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
QHM
Serology Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
PQA
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
PRA
Variola Virus Nucleic Acid-Based Detection Assay
PRH
Positive Blood Culture Identification And Ast Kit
PVQ
Rickettsia Spp. Nucleic Acid Based Detection Assay
PYN
Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
QAA
Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
QBD
Microbial Nucleic Acid Storage And Stabilization Device
QBN
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QDZ
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
QEP
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
QFA
Assay For Detection Of Proteases In Chronic Wounds
QFO
Zika Virus Serological Reagents
QHO
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
QID
Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
QNJ
Mass Spectrometry, Microorganism Identification, Blood Culture
MZP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
K
23
3352
Aptima HCV Quant Dx Assay
K
22
1007
cobas HCV
P
19
0025
Alinity m HCV
P
16
0023
APTIMA HCV QUANT DX ASSAY
P
15
0015
COBAS HCV TEST
P
10
0017
ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
P
06
0030
COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
P
02
0022
BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
P
02
0011
VERSANT HCV RNA QUALITATIVE ASSAY
P
00
0010
AMPLICOR HEPATITIS C VIRUS (HCV) TEST VERSION 2.0
Show All 11 Submissions
NCD
Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis
NWY
Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies
QPO
Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
QQV
Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
PZF
Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
QDS
Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
LOM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
LQI
Hepatitis Delta Serological Reagents
MAQ
Kit, Dna Detection, Human Papillomavirus
MHR
Test, Anti-Tumor Cell Susceptibility
MKT
Hepatitis Viral B Dna Detection
MYL
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
MYM
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
MZO
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
OIH
Yersinia Spp. Reagents
OJN
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
OJO
Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria
ORL
Whole Blood Pre-Treatment T-Cell Enrichment Reagent
OTT
Research Use Only/Microbiology
OYB
Kit, Rna Detection, Human Papillomavirus
PAB
Cytomegalovirus (Cmv) Dna Quantitative Assay
PCY
Investigational Use Only - Microbiology
POA
Reagents, Zika Virus Nucleic Acid
POG
Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid
PYS
Zika Virus Serological Reagents (Emergency Use)
QHV
Multiple Osteoarticular Pathogen Antigen Kit
QIM
Bartonella Spp. Serological Reagents
QIN
Babesia Spp. Serological Reagents
QIO
Anaplasma Spp. And Ehrlichia Spp. Serological Reagents
QIP
Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents
QIQ
Orientia Spp. (Scrub Typhus) Serological Reagents
QJR
Reagents, 2019-Novel Coronavirus Nucleic Acid
QKO
Reagent, Coronavirus Serological
QKP
Coronavirus Antigen Detection Test System.
QLT
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
QLW
Covid-19 Test Home Collection Kit Devices
QMN
Covid-19 Multi-Analyte Antigen Device
QSH
Coronavirus Marker Detection
QSN
Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System
QSS
Hiv Self-Tests
QTA
Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis
QTP
Reagents, Monkeypox Virus Nucleic Acid.
QTQ
Reagents, Non-Variola Orthopoxvirus Nucleic Acid.
QWB
Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
QVR
Multiplex Nucleic Acid Detection System For Biothreat Agents
QUU
Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
QVF
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
QVP
Sars-Cov-2 Serology Test
QWR
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
QXA
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
QYA
System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
QYT
Over-The-Counter Covid-19 Antigen Test
QZX
Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
SAN
Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples
SBP
Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
SBT
Device To Detect Microbial Colonization Directly From Clinical Specimens.
SBZ
Test For Detection Of Antibodies Associated With Syphilis Performed By Lay Users
SCA
Multi-Analyte Respiratory Virus Antigen Detection Test
SDM
Nucleic Acid Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
SDN
Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps
Submissions with No Product Code
Subpart B—Biological Stains
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart C—Clinical Laboratory Instruments
Subpart C—Microbiology Devices
Subpart D—Serological Reagents
Subpart F—Immunological Test Systems
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
MI
/
MI-misc
/
MZP
/
P150015
View Source
COBAS HCV TEST
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Roche Molecular Systems, Inc.
Trade Name
COBAS HCV TEST
Generic Name
Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision Date
10/14/2015
Days to Decision
170 days
Decision Code
APPR
FDA Decision
Approval