Alinity

Primary DI
00380740209490
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
04W1722
Catalog number
04W1722
Device description
GFAP Reagent Kit 200 Tests
Published
2023-07-11
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
QATBrain trauma assessment test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QATBrain Trauma Assessment TestImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740209490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740209490003807402094903807402094900380740209490

GMDN Terms#

Term, Definition table
TermDefinition
Multiple traumatic brain injury marker IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple biochemical markers associated with traumatic brain injury in a clinical specimen, using a chemiluminescent immunoassay method. This test is used to detect glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) as an aid to determine the need for a neuroimaging radiological scan following head injury.

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
03573026626891VIDASĀ® TBI (GFAP, UCH-L1)BIOMERIEUX SAQAT2024-10-31
10054749005779i-STAT TBI cartridgeAbbott Point of Care Inc.QAT2024-07-08
00054749005772i-STAT TBI cartridgeAbbott Point of Care Inc.QAT2024-07-08
00380740213947ARCHITECTAbbott Ireland DiagnosticsQAT2024-03-15
00380740213954ARCHITECTAbbott Ireland DiagnosticsQAT2024-03-15
00380740209469AlinityAbbott Ireland DiagnosticsQAT2023-07-11
10054749005069i-STATABBOTT POINT OF CARE INC.QAT2021-10-12
00054749005611i-STATABBOTT POINT OF CARE INC.QAT2021-10-12
00054749005062i-STATABBOTT POINT OF CARE INC.QAT2021-10-12