BIO-RAD LABORATORIES, INC.

Address:2500 Atlas Rd,Richmond,CA,94804,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) (6) ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL (DHN) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2)

Premarket Exempt

No Yes

Clear

Liquichek - 00847661000006 Catalog Number : 691

Device Description : Liquichek Unassayed Chemistry Control (Human) Level 1 (A human serum unassayed c Liquichek Unassayed Chemistry Control (Human) Level 1 (A human serum unassayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000013 Catalog Number : 692

Device Description : Liquichek Unassayed Chemistry Control (Human) Level 2 (A human serum unassayed c Liquichek Unassayed Chemistry Control (Human) Level 2 (A human serum unassayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000020 Catalog Number : 354

Device Description : Liquichek Pediatric Control Level 1 (An assayed pediatric control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquichek - 00847661000037 Catalog Number : 355

Device Description : Liquichek Pediatric Control Level 2 (An assayed pediatric control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000044 Catalog Number : 731

Device Description : Lyphochek Unassayed Chemistry Control (Human) Level 1 (A human serum unassayed c Lyphochek Unassayed Chemistry Control (Human) Level 1 (A human serum unassayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000051 Catalog Number : 732

Device Description : Lyphochek Unassayed Chemistry Control (Human) Level 2 (A human serum unassayed c Lyphochek Unassayed Chemistry Control (Human) Level 2 (A human serum unassayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000068 Catalog Number : C-320-10

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000075 Catalog Number : C-325-10

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000082 Catalog Number : 107

Device Description : Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum a Liquichek ANA Control, Homogeneous Pattern Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

Liquichek - 00847661000099 Catalog Number : 108

Device Description : Liquichek ANA Control, Speckled Pattern, Positive (A pre-diluted human serum aut Liquichek ANA Control, Speckled Pattern, Positive (A pre-diluted human serum autoimmune control.)

Device Class : 2

Duns Number: 051624070

Premarket Exempt : No

Product Code : DHN

Prescription Use : No

Device Count : 1

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