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, all kinds (assayed) (JJY) (10) ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (1) Calibrator, multi-analyte mixture (JIX) (1)

Premarket Exempt

No Yes

Clear

BioPlex 2200 - 03610522053131 Catalog Number : 12008626

Device Description : U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1

Device Class : 1

Duns Number: 884513334

Premarket Exempt : No

Product Code : JIX, JJY, NHX

Prescription Use : No

Device Count : 1

InteliQ - 03610522113842 Catalog Number : 12009941

Device Description : InteliQ Immunology Control Level 1 (A human serum assayed protein control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522113859 Catalog Number : 12009942

Device Description : InteliQ Immunology Control Level 2 (A human serum assayed protein control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522113866 Catalog Number : 12009943

Device Description : InteliQ Immunology Control Level 3 (A human serum assayed protein control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522113873 Catalog Number : 12009944

Device Description : InteliQ Immunology Control MiniPak (A human serum assayed protein control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522114184 Catalog Number : 12009948

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522114191 Catalog Number : 12009949

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522114207 Catalog Number : 12009950

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522114214 Catalog Number : 12009951

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

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

InteliQ - 03610522114320 Catalog Number : 12009955

Device Description : InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac m InteliQ Cardiac Markers Plus Control LT Level 1 (A human serum assayed cardiac markers control.)

Device Class : 1

Duns Number: 051624070

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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