FDA.reportPublic FDA data

Afinion ACR Control

Primary DI
07070060014647
Brand
Afinion ACR Control
Company
Abbott Diagnostics Technologies AS
Model
1116973
Catalog number
1116973
Device description
ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert.
Published
2019-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070060014647PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070060014647070700600146477070060014647

GMDN Terms#

Term, Definition table
TermDefinition
Microalbumin IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of microalbumin in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
07070060014722Afinion HbA1c Calibration Verification111679211167922019-05-31
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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Primary DI, Brand, Company table
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05391523442831Multichem AETECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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05391523442862Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442879Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442886Multichem IA SpecialityTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442893Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442909Multichem CSFTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442916Multichem NBTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442923Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
05391523442930Multichem D-DimerTECHNO-PATH MANUFACTURING LIMITEDJJY2026-06-02
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