FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740156992
Brand
ARCHITECT
Company
Abbott Ireland Diagnostics
Model
4P76-27
Catalog number
04P7627
Device description
ARCHITECT HBsAg Next Qualitative Reagent Kit (100T)
Published
2023-04-13
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
LOMTest, hepatitis b (b core, be antigen, be antibody, b core igm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)Microbiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740156992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740156992003807401569923807401569920380740156992

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen 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)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
985307301
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
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740168780Alinity04W022204W02222025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336160367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-10-02
07613336230367Elecsys Anti-HBs IIRoche Diagnostics GmbHLOM2024-08-20
00380740160579AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740160593AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740161262AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214289AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214296AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00380740214302AlinityAbbott Ireland DiagnosticsLOM2024-06-28
00630414637877Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2024-04-26
00630414561226ADVIA Centaur® HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414210766ADVIA Centaur® HBcT2 Quality Control KitSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604138Atellica IM HBcT2SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00630414604336Atellica IM HBcT2 QCSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLOM2023-06-20
00380740157012ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740158187ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740163389ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208462ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208479ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740208486ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
00380740171742ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740171759ARCHITECTAbbott Ireland DiagnosticsLOM2023-01-06
00380740173555AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00380740173562AlinityAbbott Ireland DiagnosticsLOM2023-01-06
00842768022678Atellica IM aHBe2Siemens Healthcare Diagnostics Inc.LOM2022-05-05
07613336203606Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336203613Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
07613336175293Elecsys HBsAg Confirmatory TestRoche Diagnostics GmbHLOM2022-01-26
00630414167923ADVIA Centaur aHBe2 50T KitSiemens Healthcare Diagnostics Inc.LOM2022-01-14
04015630940134Elecsys Anti-HBeRoche Diagnostics GmbHLOM2021-12-09
04015630938865Elecsys Anti-HBeRoche Diagnostics GmbHLOM2021-04-07