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 unassayed (OHQ) (8) Control, hemoglobin (GGM) (1) Single (specified) analyte controls (assayed and unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

Liquichek - 03610522141975 Catalog Number : 12011334

Device Description : Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed Liquichek Diabetes Control Level 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

Liquichek - 03610522142415 Catalog Number : 12011331

Device Description : Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed Liquichek Diabetes Control Level Trilevel MiniPak (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

VIROTROL - 03610522207848 Catalog Number : 200300A

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROTROL - 03610522207855 Catalog Number : 200300B

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROTROL - 03610522207862 Catalog Number : 200300C

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROTROL - 03610522207879 Catalog Number : 200305A

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROTROL - 03610522207886 Catalog Number : 200305B

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROTROL - 03610522207893 Catalog Number : 200305C

Device Description : VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROCLEAR - 03610522207923 Catalog Number : 200500

Device Description : VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

VIROCLEAR - 03610522207930 Catalog Number : 200505

Device Description : VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

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