ABBOTT IRELAND

Address:DIAGNOSTICS DIVISION,SLIGO,IE

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Filters

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

COMPLEMENT C3, ANTIGEN, ANTISERUM, CONTROL (CZW) (2) COMPLEMENT C4, ANTIGEN, ANTISERUM, CONTROL (DBI) (2) LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL (DFC) (2) NADH OXIDATION/NAD REDUCTION, ALT/SGPT (CKA) (2) ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL (DER) (1) Nadh oxidation/nad reduction, ast/sgot (CIT) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740170042 Catalog Number : 08L9244

Device Description : Activated Alanine Aminotransferase 4820 Tests

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170059 Catalog Number : 08P1824

Device Description : Activated Alanine Aminotransferase 3000 Tests

Device Class : 1

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CKA

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170066 Catalog Number : 08P2324

Device Description : Activated Aspartate Aminotransferase 3500 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : Yes

Product Code : CIT

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170134 Catalog Number : 09P4624

Device Description : Apolipoprotein A1 190 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DER

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170158 Catalog Number : 09P4724

Device Description : Apolipoprotein B 190 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DFC

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740170165 Catalog Number : 09D9324

Device Description : Apolipoprotein B 243 tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DFC

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170172 Catalog Number : 09P5624

Device Description : Complement C3 300 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : CZW

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740170189 Catalog Number : 09D9624

Device Description : Complement C3 279 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : CZW

Prescription Use : Yes

Device Count : 1

Alinity - 00380740170196 Catalog Number : 09P5724

Device Description : Complement C4 300 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DBI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740170202 Catalog Number : 09D9724

Device Description : Complement C4 279 Tests

Device Class : 2

Duns Number: 989964119

Premarket Exempt : No

Product Code : DBI

Prescription Use : Yes

Device Count : 1

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