BIO-RAD LABORATORIES, INC.

Address:800 Alfred Nobel Drive,Hercules,CA,94547,US

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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

Multi-analyte controls, all kinds (assayed) (JJY) (6) Control, hemoglobin (GGM) (4)

Premarket Exempt

No Yes

Clear

InteliQ - 03610522046065 Catalog Number : 12008291

Device Description : InteliQ Tumor Marker Control Level 3 (A human based assayed tumor marker control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046072 Catalog Number : 12008292

Device Description : InteliQ Tumor Marker Control MiniPak (A human based assayed tumor marker control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046140 Catalog Number : 12008299

Device Description : InteliQ Ethanol/Ammonia Control Level 1 (An assayed ethanol and ammonia control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046157 Catalog Number : 12008300

Device Description : InteliQ Ethanol/Ammonia Control Level 2 (An assayed ethanol and ammonia control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046164 Catalog Number : 12008301

Device Description : InteliQ Ethanol/Ammonia Control Level 3 (An assayed ethanol and ammonia control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046171 Catalog Number : 12008302

Device Description : InteliQ Ethanol/Ammonia Control MiniPak (An assayed ethanol and ammonia control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046249 Catalog Number : 12008309

Device Description : InteliQ Diabetes Control Level 1 (A human whole blood assayed diabetes control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : No

Device Count : 1

InteliQ - 03610522046256 Catalog Number : 12008310

Device Description : InteliQ Diabetes Control Level 2 (A human whole blood assayed diabetes control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : No

Device Count : 1

InteliQ - 03610522046263 Catalog Number : 12008311

Device Description : InteliQ Diabetes Control Level 3 (A human whole blood assayed diabetes control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : No

Device Count : 1

InteliQ - 03610522046270 Catalog Number : 12008312

Device Description : InteliQ Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : GGM

Prescription Use : No

Device Count : 1

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