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

ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL (DHN) (3) HEAVY METALS CONTROL MATERIALS (DIE) (2) Multi-analyte controls unassayed (OHQ) (2) Multi-analyte controls, all kinds (assayed) (JJY) (2) DRUG MIXTURE CONTROL MATERIALS (DIF) (1)

Premarket Exempt

No Yes

Clear

Liquichek - 00847661000204 Catalog Number : 129

Device Description : Liquichek Anti-Smooth Muscle Control, Positive (A pre-diluted human serum autoim Liquichek Anti-Smooth Muscle Control, 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 - 00847661000211 Catalog Number : 131

Device Description : Liquichek ANA Controls Set, 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 - 00847661000228 Catalog Number : 130

Device Description : Liquichek Autoimmune Negative Control (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 - 00847661000235 Catalog Number : 239

Device Description : Liquichek ToRCH Plus Control, Positive (An unassayed (human) Serology control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000259 Catalog Number : 228

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : No

Device Count : 1

Liquichek - 00847661000266 Catalog Number : 229

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Liquichek - 00847661000273 Catalog Number : 230

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000280 Catalog Number : 400

Device Description : Lyphochek Urine Metals Control Level 1 (A human urine assayed metals control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : DIE

Prescription Use : No

Device Count : 1

Lyphochek - 00847661000297 Catalog Number : 405

Device Description : Lyphochek Urine Metals Control Level 2 (A human urine assayed metals control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : DIE

Prescription Use : No

Device Count : 1

Liquichek - 00847661000303 Catalog Number : 460

Device Description : Liquichek Urine Toxicology Negative Control (A human urine drugs of abuse control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : No

Product Code : DIF

Prescription Use : No

Device Count : 1

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