FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740011130
Brand
ARCHITECT
Company
Abbott GmbH
Model
6L23-01
Catalog number
06L2301
Device description
ARCHITECT CORE-M Calibrators
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
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P060035001
P060035002
P060035003
P060035006
P060035008
P060035038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P060035001ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI
P060035002ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI
P060035003ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI
P060035006ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI
P060035008ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI
P060035038ARCHITECT CORE-M REAGENT KIT/CALIBRATORS/CONTROLSAbbott Laboratories2007-11-06SEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740011130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740011130003807400111303807400111300380740011130

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.

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
00380740186173Alinity04T971A04T971A2026-10-15
00380740186180Alinity04T973A04T973A2026-10-15
00380740186197Alinity04T975A04T975A2026-10-15
00380740150662Alinity09P562009P56202019-06-27
00380740150679Alinity09P572009P57202019-06-27
00380740150693Alinity09P632009P63202019-07-08
00380740153922Alinity09P622009P62202019-12-24
00380740199265Alinity06T790106T79012026-09-04
00380740199272Alinity06T791006T79102026-09-04
00380740208899Alinity06T792106T79212026-09-04
00380740208905Alinity06T793106T79312026-09-04
00380740223724Alinity06T793A06T793A2026-09-04
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

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00380740157012ARCHITECTAbbott Ireland DiagnosticsLOM2023-04-13
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07613336203606Elecsys Anti-HBc IIRoche Diagnostics GmbHLOM2022-04-11
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00630414167923ADVIA Centaur aHBe2 50T KitSiemens Healthcare Diagnostics Inc.LOM2022-01-14
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