FDA.report

Alinity

Primary DI
00380740135591
Brand
Alinity
Company
Abbott GmbH & Co. KG
Model
08P4320
Catalog number
08P4320
Device description
Alinity c Hemoglobin A1c Reagent Kit 1300 Tests
Published
2019-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PDJHemoglobin A1c test system

Product Code Classifications

CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740135591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135591003807401355913807401355910380740135591

GMDN Terms

TermDefinition
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
315786293
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 DIBrandModelCatalogPublished
00380740138332Alinity07P603107P60312020-05-29
00380740192457Alinity06R901A06R901A2020-05-18
00380740170264Alinity09P521A09P521A2020-05-11
00380740170271Alinity09P523A09P523A2020-05-11
00380740121754Alinity08P072108P07212020-05-06
00380740121778Alinity08P073108P07312020-05-06
00380740136574Alinity08P071208P07122020-05-06
00380740146252Alinity08P070208P07022020-05-06
00380740151744Alinity09P411A09P411A2020-05-01
00380740154387Alinity08P073A08P073A2020-05-01
00380740163556ARCHITECT5P56-0205P56022020-05-02
00380740161798ARCHITECT7D79-2207D79222020-04-18
00380740161804ARCHITECT7D79-3207D79322020-04-18
00380740190361ARCHITECT08K280408K28042020-04-15
00380740190378ARCHITECT08K281308K28132020-04-15
00380740154325Alinity09P140309P14032018-07-30
00380740174965ARCHITECT6L45-2206L45222020-04-12
00380740174972ARCHITECT6L45-4206L45422020-04-12
00380740170318Alinity09P551A09P551A2020-03-27
00380740170325Alinity09P553A09P553A2020-03-27

Other Devices Sharing Product Codes

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06935784430016BioHermes Automated Glycohemoglobin AnalyzerWuxi Biohermes Bio & Medical Technology Co.,Ltd.PDJ2022-01-04
07613336120927Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07070060014555Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2019-05-31
15099590012120AU BECKMAN COULTER IRELAND INC.PDJ2019-02-13
00630414006666Dimension Vista System Flex reagent cartridge A1C KITSiemens Healthcare Diagnostics Inc.PDJ2019-02-12
00630414006659Dimension Clinical Chemistry System A1C KitSiemens Healthcare Diagnostics Inc.PDJ2018-12-06
07070060012889Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2018-11-01
00628063401147HbA1c AssaySEKISUI DIAGNOSTICS, LLCPDJ2018-09-24
14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
14987486015106ELUENT 80BARKRAY USA, INC.PDJ2018-02-08
14987486015113ELUENT 80CVARKRAY USA, INC.PDJ2018-02-08
04987486015130DILUENT 80ARKRAY USA, INC.PDJ2018-02-08
04987486001973ADAMS™ A1c HA-8180V (UL) AnalyzerARKRAY USA, INC.PDJ2017-12-08
14987486015120HEMOLYSIS WASHING SOLUTION 80HARKRAY USA, INC.PDJ2017-12-08
03610520530108D-10BIO-RAD LABORATORIES, INC.PDJ2017-07-21
03610521164302D-10BIO-RAD LABORATORIES, INC.PDJ2017-07-21
03610521164319D-10BIO-RAD LABORATORIES, INC.PDJ2017-07-21
00847817016028D-100BIO-RAD LABORATORIES, INC.PDJ2016-09-12
00847817016035D-100BIO-RAD LABORATORIES, INC.PDJ2016-09-12
00847817025679D-100BIO-RAD LABORATORIES, INC.PDJ2016-09-12
00847817025693D-100BIO-RAD LABORATORIES, INC.PDJ2016-09-12
00380740102739ARCHITECTABBOTT LABORATORIESPDJ2016-09-09
00380740102746ARCHITECTABBOTT LABORATORIESPDJ2016-09-09
10758750030729VITROSORTHO-CLINICAL DIAGNOSTICS, INC.PDJ2016-08-10