Alinity

Primary DI
00380740202859
Brand
Alinity
Company
ABBOTT LABORATORIES
Model
06P0161
Catalog number
06P0161
Device description
Alinity s HIV Ag/Ab Combo Reagent Kit
Published
2025-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740202859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740202859003807402028593807402028590380740202859

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an chemiluminescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03
00380740202835Alinity06P012506P01252025-10-03
00380740202996Alinity06P080706P08072025-09-17
00380740203023Alinity06P081506P08152025-09-17
00380740203030Alinity06P082506P08252025-09-17
00380740203054Alinity06P086106P08612025-09-17
00380740196257GLP systems Track04Z965104Z96512023-08-30
00380740225186ARCHITECT04P553004P55302026-05-14
00380740225193ARCHITECT04P573304P57332026-05-14
00380740003197ARCHITECT2K41-1002K41102016-06-06
00380740138851Alinity09P680109P68012023-11-16
00380740138868Alinity09P690109P69012023-11-16
00380740203191Alinity06P023006P02302025-09-24
00380740203214Alinity06P020606P02062025-09-24
00380740203238Alinity06P022006P02202025-09-24
00380740203252Alinity06P026106P02612025-09-24
00380740203276Alinity06P035806P03582025-09-24
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24