FDA.reportPublic FDA data

Alinity

Primary DI
00380740135201
Brand
Alinity
Company
Abbott GmbH
Model
08P0420
Catalog number
08P0420
Device description
Alinity c Microalbumin Reagent Kit 640 Tests
Published
2018-08-31
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
JIQTURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740135201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135201003807401352013807401352010380740135201

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of microalbumin in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
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
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
00380740190316ARCHITECTABBOTT IRELANDJIQ2022-05-25
00380740190781AlinityABBOTT IRELANDJIQ2022-02-28
04987481164666Autokit Micro AlbuminFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIQ2021-07-30
00192024031143Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024031150Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068545Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
00192024068552Ricca Chemical Company®Ricca Chemical Company, LLCJIQ2021-02-04
03610230008621Yumizen C1200 Urinary ProteinsHORIBA ABX SASJIQ2020-09-09
00380740119416ARCHITECTAbbott GmbHJIQ2017-01-31
00380740119393ARCHITECTAbbott GmbHJIQ2016-12-31
00380740119409ARCHITECTAbbott GmbHJIQ2016-12-31
05060500090005Synermed®INFRARED LABORATORY SYSTEMS LLCJIQ2016-09-20
00380740003630ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003647ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
00380740003654ARCHITECTABBOTT LABORATORIESJIQ2016-09-09
15099590180164IMMAGE Beckman Coulter, Inc.JIQ2016-08-24
03610230005057ABX PENTRA URINARY PROTEINS CPHORIBA ABX SASJIQ2016-08-23