FDA.reportPublic FDA data

Afinion HbA1c Calibration Verification

Primary DI
07070060014722
Brand
Afinion HbA1c Calibration Verification
Company
Abbott Diagnostics Technologies AS
Model
1116792
Catalog number
1116792
Device description
HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert.
Published
2019-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070060014722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070060014722070700600147227070060014722

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
515324122
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07070060015798Afinion HbA1c Calibration Verification11167922024-03-21
07070060008042Alere Afinion™ AS100111539011153902023-10-26
07070060014616Afinion™ 2111697011169702023-10-26
07070060014623Afinion™ 2111697111169712023-10-26
07070060014692Afinion™ 2111698511169852023-10-26
07070060014708Afinion™ 2111698611169862023-10-26
07070060014555Afinion HbA1c Dx111679411167942019-05-31
07070060014630Afinion ACR111697211169722019-05-16
07070060014654Afinion HbA1c111697411169742019-05-16
07070060014647Afinion ACR Control111697311169732019-05-16
07070060014661Afinion HbA1c Control111697511169752019-05-16
07070060005683Alere Afinion™ HbA1c111501511150152016-09-16
07070060005744Alere Afinion™ ACR111502011150202016-09-16
07070060006505Alere Afinion HbA1c Control111517811151782018-05-07
07070060006765Alere Afinion ACR Control111523911152392018-05-07
07070060012889Afinion HbA1c Dx111648211164822018-11-01

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