FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740001421
Brand
ARCHITECT
Company
Abbott GmbH
Model
1L79-35
Catalog number
01L7935
Device description
ARCHITECT Anti-HCV Reagent Kit
Published
2014-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P050042002
P050042003
P050042005
P050042006
P050042007
P050042010
P050042012
P050042042
P050042045

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P050042002ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042003ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042005ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042006ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042007ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042010ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042012ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042042ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO
P050042045ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROLAbbott Laboratories, Inc.2006-06-07MZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740001421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740001421003807400014213807400014210380740001421

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis C virus total antibody IVD, kit, chemiluminescent assayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis C virus in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xxx@xxx.xxx

Regulatory Flags#

DUNS number
315786293
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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
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
00608337000535OraQuick HCV Rapid Antibody TestOrasure Technologies, Inc.MZO2014-09-05