Afinion? HbA1c, Afinion? 2 and Alere Afinion? AS100 Analyzer
Abbott Diagnostics Technologies AS
Abbott Diagnostics Technologies AS
PMN#
GUDID#
Afinion HbA1c Calibration Verification - HbA1c Calibration Verification for use with the Afinion™ HbA1c test. Content: 1 Control C I. 1 Control C II. 1 package insert
2024-03-21
Alere Afinion™ AS100 - 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
2023-10-26
Afinion™ 2 - 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
2023-10-26
Afinion™ 2 - 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
2023-10-26
Afinion™ 2 - 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
2023-10-26
Afinion™ 2 - 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
2023-10-26
Afinion HbA1c Dx - Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert.
2019-05-31
Afinion ACR - Albumin/Creatinine ration test kit. Intended use: For the determination of albumin, creatinine and albumin/creatinine ration in human urine. Contetns: 15 test cartridges. 1 package insert.
2019-05-16
Afinion HbA1c - Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert
2019-05-16
Afinion HbA1c Calibration Verification - HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert.
2019-05-31
Afinion ACR Control - ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert.
2019-05-16
Afinion HbA1c Control - HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert.
2019-05-16
Alere Afinion™ HbA1c - Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 Test Cartridges. 1 Package Insert. DI covers Alere Afinion HbA1c and Afinion HbA1c.
2016-09-16
Alere Afinion™ ACR - Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumin, creatinine and the albumin/creatinine ratio in human urine. Contents: 15 Test Cartridges. 1 Package insert. DI covers Alere Afinion ACR and Afinion ACR.
2016-09-16
Alere Afinion HbA1c Control - HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. Content: 1 Control C1. 1 Control C II. 1 package insert. DI covers Alere Afinion HbA1c Control and Afinion HbA1c Control.
2018-05-07
Alere Afinion ACR Control - 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.
2018-05-07
Afinion HbA1c Dx - Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert.
2018-11-01