	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. Afinion ACR - 1116972
	ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert. Afinion ACR Control - 1116973
	Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood. Contents: 15 test cartridges, 1 package insert Afinion HbA1c - 1116974
	HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert. Afinion HbA1c Calibration Verification - 1116792
	HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert. Afinion HbA1c Control - 1116975
	Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert. Afinion HbA1c Dx - 1116482
	Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert. Afinion HbA1c Dx - 1116794
	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 Afinion™ 2 - 1116970
	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 Afinion™ 2 - 1116971
	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 Afinion™ 2 - 1116985
	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 Afinion™ 2 - 1116986
	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. Alere Afinion ACR Control - 1115239
	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. Alere Afinion HbA1c Control - 1115178
	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. Alere Afinion™ ACR - 1115020
	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 Alere Afinion™ AS100 - 1115390
	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. Alere Afinion™ HbA1c - 1115015

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