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

Multi-analyte controls, all kinds (assayed) (JJY) (10)

Premarket Exempt

No Yes

Clear

InteliQ - 03610522045822 Catalog Number : 12008257

Device Description : InteliQ Assayed Multiqual Control Level 2 (A human serum assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045839 Catalog Number : 12008258

Device Description : InteliQ Assayed Multiqual Control Level 3 (A human serum assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045846 Catalog Number : 12008259

Device Description : InteliQ Assayed Multiqual Control MiniPak (A human serum assayed chemistry control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045914 Catalog Number : 12008276

Device Description : InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoass InteliQ Specialty Immunoassay Control Level LTA (A human serum assayed immunoassay control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045921 Catalog Number : 12008277

Device Description : InteliQ Specialty Immunoassay Control Level 1 (A human serum assayed immunoassay control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045938 Catalog Number : 12008278

Device Description : InteliQ Specialty Immunoassay Control Level 2 (A human serum assayed immunoassay control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045945 Catalog Number : 12008279

Device Description : InteliQ Specialty Immunoassay Control Level 3 (A human serum assayed immunoassay control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522045952 Catalog Number : 12008280

Device Description : InteliQ Specialty Immunoassay Control MiniPak (A human serum assayed immunoassay control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046041 Catalog Number : 12008289

Device Description : InteliQ Tumor Marker Control Level 1 (A human based assayed tumor marker control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522046058 Catalog Number : 12008290

Device Description : InteliQ Tumor Marker Control Level 2 (A human based assayed tumor marker control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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