FDA.reportPublic FDA data

OraQuick HCV Rapid Antibody Test

Primary DI
00608337000535
Brand
OraQuick HCV Rapid Antibody Test
Company
Orasure Technologies, Inc.
Model
3001-1521
Published
2014-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MZOAssay,Enzyme Linked Immunosorbent,Hepatitis C Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C VirusMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P080027001
P080027003
P080027005
P080027006
P080027007
P080027008
P080027009
P080027010
P080027011
P080027012
P080027013
P080027014
P080027015
P080027016

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P080027001ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027003ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027005ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027006ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027007ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027008ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027009ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027010ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027011ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027012ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027013ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027014ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027015ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO
P080027016ORAQUICK HCV RAPID ANTIBODY TESTOraSure Technologies, Inc.2010-06-25MZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10608337000532PackageGS1100In Commercial Distribution
20608337000539PackageGS125In Commercial Distribution
00608337000535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060833700053210608337000532
2060833700053920608337000539
00608337000535006083370005356083370005350608337000535

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus total antibody IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
610-882-1820customercare@orasure.com

Regulatory Flags#

DUNS number
114152184
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00608337000115OraSure Oral Fluid Collection Device3001-28702019-02-15
00608337000559Histofreezer1001-03752016-09-15
00608337360103Histofreezer1001-02952016-09-15
00608337365108Histofreezer1001-02942016-09-15
00608337402100Histofreezer1001-02932016-09-15
20608337000065OraSure Quick Flu 22-Count Flu A + B Kit1001-03202016-11-10
00608337000047OraSure Quickflu Nasopharyngeal Wash / Aspirate1001-03212016-11-25
00608337000054OraSure QuickFlu Positive and Negative Control Kit1001-03232018-03-23
00608337001297Histofreezer1001-03362016-09-16
10608337001850OraQuick HIV Self-Test3001-3822U22026-05-08
00608337001860OraQuick HIV Self-Test3001-3822UR22026-05-08
00608337000078Intercept3001-28692016-07-29
00608337150308Q.E.D. Saliva Alcohol Test A150601562016-07-29
00608337000030Kit, MP Cotinine Serum 100 plate1124EC2021-01-22
00608337000023Methamphetamine Intercept 2 Plate Kit1104IT2016-09-12
00608337000085Auto-Lyte1224UM1224UM2016-04-29
00608337000146Amphetamine Intercept 5 Plate Kit1103IB2016-09-12
00608337000153Amphetamine Intercept 100 Plate Kit1103IC2016-09-12
00608337000184Methamphetamine Intercept 5 Plate Kit1104IB2016-09-12
00608337000191Methamphetamine Intercept 100 Plate Kit1104IC2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217092Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2025-10-27
07613336166956Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
07613336166970Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
07613336166994Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2023-01-23
00630414301341Atellica IM aHCV 200TSiemens Healthcare Diagnostics Inc.MZO2021-01-15
00380740130633AlinityAbbott GmbHMZO2019-10-11
00380740130640AlinityAbbott GmbHMZO2019-10-11
00380740130657AlinityAbbott GmbHMZO2019-10-11
00630414278742Atellica IM aHCV 200TSiemens Healthcare Diagnostics Inc.MZO2018-11-01
00630414278759ADVIA Centaur HCVSiemens Healthcare Diagnostics Inc.MZO2018-11-01
00630414597867Atellica™ IM aHCVSiemens Healthcare Diagnostics Inc.MZO2018-10-16
00630414597874Atellica™ IM aHCV QCSiemens Healthcare Diagnostics Inc.MZO2018-10-16
04015630939947Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-12-18
07613336154304Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-10-03
07613336154311Elecsys Anti-HCV IIRoche Diagnostics GmbHMZO2017-10-03
07613336154328PreciControl Anti-HCVRoche Diagnostics GmbHMZO2017-10-03
04015630936663Elecsys AntiHCV II immunoassayRoche Diagnostics GmbHMZO2015-09-21
04015630936670Elecsys AntiHCV II immunoassayRoche Diagnostics GmbHMZO2015-09-21
M769HCV271Hepatitis C CheckHome Access Health CorporationMZO2015-09-03
04015630919277Elecsys PreciControl Anti-HCVRoche Diagnostics GmbHMZO2014-12-18
00380740001391ARCHITECTAbbott GmbHMZO2014-11-18
00380740001407ARCHITECTAbbott GmbHMZO2014-11-18
00380740001414ARCHITECTAbbott GmbHMZO2014-11-18
00380740001421ARCHITECTAbbott GmbHMZO2014-11-18
10758750001095VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-24
10758750001101VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-22
10758750002801VITROSORTHO CLINICAL DIAGNOSTICSMZO2014-10-22
00630414473161ADVIA Centaur® HCVSiemens Healthcare Diagnostics Inc.MZO2014-09-24
00630414473178ADVIA Centaur® Systems HCV QCSiemens Healthcare Diagnostics Inc.MZO2014-09-24
04015630919260Elecsys Anti-HCV ImmunoassayRoche Diagnostics GmbHMZO2014-09-11