FDA.reportPublic FDA data

Alere Afinion ACR Control

Primary DI
07070060006765
Brand
Alere Afinion ACR Control
Company
Abbott Diagnostics Technologies AS
Model
1115239
Catalog number
1115239
Device description
ACR Control for use with the Alere Afinion ACR test and Afinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. DI covers Alere Afinion ACR Control and and Afinion ACR Control.
Published
2018-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070060006765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070060006765070700600067657070060006765

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
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
515324122
Device count
1
Premarket exempt
true
Kit
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
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
07070060012889Afinion HbA1c Dx111648211164822018-11-01