BIO-RAD LABORATORIES, INC.

Address:4000 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

URINALYSIS CONTROLS (ASSAYED AND UNASSAYED) (JJW) (3) DRUG MIXTURE CONTROL MATERIALS (DIF) (2) DRUG SPECIFIC CONTROL MATERIALS (LAS) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2) Multi-analyte controls unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

Liquichek - 00847661000518 Catalog Number : 230NX

Device Description : Liquichek ToRCH Plus IgM Control, Negative MiniPak (A human serology IgM Control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquichek - 00847661000532 Catalog Number : 228X

Device Description : Liquichek ToRCH Plus Control, Negative MiniPak (An unassayed (human) serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000549 Catalog Number : 436

Device Description : Liquichek Urinalysis Control Level 1 (An assayed human urinalysis control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Liquichek - 00847661000556 Catalog Number : 437

Device Description : Liquichek Urinalysis Control Level 2 (An assayed human urinalysis control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Liquichek - 00847661000563 Catalog Number : 435

Device Description : Liquichek Urinalysis Control Bilevel (An assayed human urinalysis control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJW

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000570 Catalog Number : 661

Device Description : Lyphochek Benzo/TCA Control- Set A Level 1 (A human serum assayed benzodiazepine Lyphochek Benzo/TCA Control- Set A Level 1 (A human serum assayed benzodiazepines and TCA control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : LAS

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000587 Catalog Number : 662

Device Description : Lyphochek Benzo/TCA Control- Set A Level 2 (A human serum assayed benzodiazepine Lyphochek Benzo/TCA Control- Set A Level 2 (A human serum assayed benzodiazepines and TCA control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : LAS

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000594 Catalog Number : 663

Device Description : Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepine Lyphochek Benzo/TCA Control- Set B Level 1 (A human serum assayed benzodiazepines and TCA control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000600 Catalog Number : 664

Device Description : Lyphochek Benzo/TCA Control- Set B Level 2 (A human serum assayed benzodiazepine Lyphochek Benzo/TCA Control- Set B Level 2 (A human serum assayed benzodiazepines and TCA control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

Liquichek - 00847661000617 Catalog Number : 180

Device Description : Liquichek Cardiac Markers Plus Control Trilevel (A human serum assayed cardiac m Liquichek Cardiac Markers Plus Control Trilevel (A human serum assayed cardiac markers control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

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