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) (4) Control, hemoglobin (GGM) (3) Single (specified) analyte controls (assayed and unassayed) (JJX) (3)

Premarket Exempt

No Yes

Clear

InteliQ - 03610522114436 Catalog Number : 12009966

Device Description : InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed InteliQ Cardiac Markers Plus Control LT Level 1C MiniPak (A human serum assayed cardiac markers control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522115945 Catalog Number : 12009997

Device Description : InteliQ Urine Chemistry Control Bilevel MiniPak (A human urine assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522115952 Catalog Number : 12009995

Device Description : InteliQ Urine Chemistry Control Level 1 (A human urine assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522115969 Catalog Number : 12009996

Device Description : InteliQ Urine Chemistry Control Level 2 (A human urine assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquichek - 03610522141685 Catalog Number : 12011308

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Liquichek - 03610522141692 Catalog Number : 12011309

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Liquichek - 03610522141708 Catalog Number : 12011310

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Liquichek - 03610522141944 Catalog Number : 12011343

Device Description : Liquichek 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

Liquichek - 03610522141951 Catalog Number : 12011344

Device Description : Liquichek 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

Liquichek - 03610522141968 Catalog Number : 12011345

Device Description : Liquichek 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

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