Abbott Diagnostics Technologies AS

Address:Kjelsaasveien 161,OSLO,NO

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzymatic Method, Creatinine (JFY) (3) Hemoglobin A1c Test System (PDJ) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Assay, Glycosylated Hemoglobin (LCP) (1) Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) (JIR) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

No Yes

Clear

Alere Afinion™ HbA1c - 07070060005683 Catalog Number : 1115015

Device Description : Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu 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.

Device Class : 2

Duns Number: 515324122

Premarket Exempt : No

Product Code : LCP

Prescription Use : Yes

Device Count : 1

Alere Afinion™ ACR - 07070060005744 Catalog Number : 1115020

Device Description : Albumin/Creatinine Ratio test kit. Intended use: For the determination of albumi 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.

Device Class : 1

Duns Number: 515324122

Premarket Exempt : No

Product Code : JFY, JIR

Prescription Use : Yes

Device Count : 1

Alere Afinion HbA1c Control - 07070060006505 Catalog Number : 1115178

Device Description : HbA1c Contols for use with the Alere Afinion HbA1c test and Afinion HbA1c test. 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.

Device Class : 1

Duns Number: 515324122

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Alere Afinion ACR Control - 07070060006765 Catalog Number : 1115239

Device Description : ACR Control for use with the Alere Afinion ACR test and Afinion ACR test. Conten 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.

Device Class :

Duns Number: 515324122

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Afinion HbA1c Dx - 07070060012889 Catalog Number : 1116482

Device Description : Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in hu Hemoglobin A1c test kit. Intended use: For determination of hemoglobin A1c in human whole blood including diagnosis. Contents: 15 Test Cartridges. 1 Package Insert.

Device Class : 2

Duns Number: 515324122

Premarket Exempt : No

Product Code : PDJ

Prescription Use : Yes

Device Count : 1

Afinion HbA1c Dx - 07070060014555 Catalog Number : 1116794

Device Description : Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in hum Hemoglobin A1c test kit. Intended use: For determination of hemogobin A1c in human whole blood including diagnosis. COntetns: 15 test cartridges, 1 package insert.

Device Class : 2

Duns Number: 515324122

Premarket Exempt : No

Product Code : PDJ

Prescription Use : Yes

Device Count : 1

Afinion ACR - 07070060014630 Catalog Number : 1116972

Device Description : Albumin/Creatinine ration test kit. Intended use: For the determination of album 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.

Device Class : 2

Duns Number: 515324122

Premarket Exempt : No

Product Code : JFY

Prescription Use : Yes

Device Count : 1

Afinion ACR Control - 07070060014647 Catalog Number : 1116973

Device Description : ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Contro ACR Controls for use with theAfinion ACR test. Contents: 1 Control C I, 1 Control C II, 1 package insert.

Device Class : 1

Duns Number: 515324122

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Afinion HbA1c - 07070060014654 Catalog Number : 1116974

Device Class : 2

Duns Number: 515324122

Premarket Exempt : No

Product Code : JFY

Prescription Use : Yes

Device Count : 1

Afinion HbA1c Control - 07070060014661 Catalog Number : 1116975

Device Description : HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 C HbA1x Controls for use with the Afinion HbA1c test. Contents: 1 Control C I, 1 Control C II, 1 package insert.

Device Class : 1

Duns Number: 515324122

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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