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Afinion™ 2

Primary DI
07070060014708
Brand
Afinion™ 2
Company
Abbott Diagnostics Technologies AS
Model
1116986
Catalog number
1116986
Device description
Afinion 2 is a compact, fully automated, multi-assay analyzer for professional near-patient testing and laboratory use. Afinion 2 is designed for use with the Afinion Test Cartridges only. The Afinion 2 System, consisting of Afinion 2 Analyzer with Afinion Test Cartridges and Afinion Controls, is intended for in vitro diagnostic use only. Contents: 1 Afinion 2 Analyzer
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClinicaClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070060014708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070060014708070700600147087070060014708

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, point-of-careA portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
515324122
Device count
1
Kit
true
Lot or batch
true
Manufacturing 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
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
07070060006765Alere Afinion ACR Control111523911152392018-05-07
07070060012889Afinion HbA1c Dx111648211164822018-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07070060008042Alere Afinion™ AS100Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014616Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014623Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014692Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
EVIRUVCCAM1ViraChip ReaderViramed Biotech AGJQT2023-07-17
EVIRUVCSCA1ViraChip ScannerViramed Biotech AGJQT2023-07-17
04049016068785EUROLineScanEUROIMMUN Medizinische Labordiagnostika AGJQT2022-12-08
00895160002014Nano-CheckerTM 710 ReaderNANO-DITECH CORPORATIONJQT2019-03-29
00867802000290xReader SystemESCREEN, INC.JQT2016-09-16
00816057020041ASiManager-ATARLINGTON SCIENTIFIC, INC.JQT2016-07-08