FDA.reportPublic FDA data

Alere Afinion™ AS100

Primary DI
07070060008042
Brand
Alere Afinion™ AS100
Company
Abbott Diagnostics Technologies AS
Model
1115390
Catalog number
1115390
Device description
Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data ConnectivityConverter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro diagnostic use only.Contents: 1 Alere Afinion AS100
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151809000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151809000Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS2015-09-25LCP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07070060008042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07070060008042070700600080427070060008042

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 Temperature-40 Degrees Celsius70 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
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
07070060006765Alere Afinion ACR Control111523911152392018-05-07
07070060012889Afinion HbA1c Dx111648211164822018-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07070060014616Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014623Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014692Afinion™ 2Abbott Diagnostics Technologies ASJQT2023-10-26
07070060014708Afinion™ 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