FDA.reportPublic FDA data

Alinity

Primary DI
00380740131364
Brand
Alinity
Company
Abbott GmbH
Model
08P2710
Catalog number
08P2710
Device description
Alinity i HAVAb IgG Controls
Published
2020-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJXKit, serological, positive control
MJYKit, serological, negative control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJXKit, Serological, Positive ControlClinical Chemistry1
MJYKit, Serological, Negative ControlClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740131364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740131364003807401313643807401313640380740131364

GMDN Terms#

Term, Definition table
TermDefinition
Hepatitis B virus core antigen 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 Hepatitis B virus core antigen in a clinical specimen.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
315786293
Device count
1
Premarket exempt
true
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
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJX2024-03-15
15099590745172ACCESS HIV Ag/Ab combo QCBeckman Coulter, Inc.MJY2024-03-15
00840733103476RSV Positive ControlMERIDIAN BIOSCIENCE, INC.MJX2021-06-18
10758750001149VITROSORTHO CLINICAL DIAGNOSTICSMJX2020-04-01
05055273216387SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)RANDOX LABORATORIES LIMITEDMJY2020-01-22
05055273216394SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)RANDOX LABORATORIES LIMITEDMJX2020-01-22
00816784020413ACCURUN®Lgc Clinical Diagnostics, Inc.MJX2018-09-24
00380740011161ARCHITECTAbbott GmbHMJY2016-09-09
00380740011161ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJX2016-09-09
00380740011178ARCHITECTAbbott GmbHMJY2016-09-09
00380740011185ARCHITECTAbbott GmbHMJX2016-09-09
00380740011185ARCHITECTAbbott GmbHMJY2016-09-09