BIOCHECK, INC.

Address:425 Eccles Avenue,South San Francisco,CA,94080,US

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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

Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (2) C-Reactive Protein, Antigen, Antiserum, And Control (DCK) (1) Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine (KLI) (1) Ferritin, Antigen, Antiserum, Control (DBF) (1) Ige, Antigen, Antiserum, Control (DGC) (1) Radioimmunoassay, Testosterones And Dihydrotestosterone (CDZ) (1) Radioimmunoassay, Total Triiodothyronine (CDP) (1) Amplifier And Signal Conditioner, Biopotential (DRR) (1) Visual, Pregnancy Hcg, Prescription Use (JHI) (1)

Premarket Exempt

Clear

BioCheck TSH EIA Test Kit - 00850392007015 Catalog Number : BC-1001

Device Description : The BioCheck TSH EIA Test Kit is intended for the quantitative determination of The BioCheck TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

BioCheck U-TSH EIA Test Kit - 00850392007039 Catalog Number : BC-1003

Device Description : The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination o The BioCheck U-TSH EIA Test Kit is intended for the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : JLW

Prescription Use : No

Device Count : 1

BioCheck T3 EIA Test Kit - 00850392007053 Catalog Number : BC-1005

Device Description : The BioCheck T3 EIA Test Kit is intended for the quantitative determination of t The BioCheck T3 EIA Test Kit is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : CDP

Prescription Use : No

Device Count : 1

BioCheck T4 EIA Test Kit - 00850392007077 Catalog Number : BC-1007

Device Description : The BioCheck T4 EIA Test Kit is intended for the quantitative determination of t The BioCheck T4 EIA Test Kit is intended for the quantitative determination of total thyroxine (T4) concentration in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : KLI

Prescription Use : No

Device Count : 1

BioCheck Testosterone EIA Test Kit - 00850392007152 Catalog Number : BC-1115

Device Description : The BioCheck Testosterone EIA Test Kit is intended for the quantitative determin The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of testosterone concentration in human serum.

Device Class : 1

Duns Number: 171857493

Premarket Exempt : No

Product Code : CDZ

Prescription Use : No

Device Count : 1

BioCheck Myoglobin EIA Test Kit - 00850392007176 Catalog Number : BC-1117

Device Description : The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determinati The BioCheck Myoglobin EIA Test Kit is intended for the quantitative determination of myoglobin in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : DRR

Prescription Use : No

Device Count : 1

BioCheck High Sensitive CRP EIA Test Kit - 00850392007190 Catalog Number : BC-1119

Device Description : BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Re BioCheck HS-CRP ELISA Kit is intended for the quantitative determination of C-Reactive Protein (CRP) in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : DCK

Prescription Use : No

Device Count : 1

BioCheck Human Ferritin EIA Test Kit - 00850392007251 Catalog Number : BC-1025

Device Description : The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determ The BioCheck Human Ferritin EIA Test Kit is intended for the quantitative determination of ferritin in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : DBF

Prescription Use : No

Device Count : 1

BioCheck hCG EIA Test Kit - 00850392007275 Catalog Number : BC-1027

Device Description : The BioCheck hCG EIA Test Kit is intended for the quantitative determination of The BioCheck hCG EIA Test Kit is intended for the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : JHI

Prescription Use : No

Device Count : 1

BioCheck IgE EIA Test Kit - 00850392007350 Catalog Number : BC-1035

Device Description : BioCheck IgE EIA Test Kit is intended for the quantitative determination of immu BioCheck IgE EIA Test Kit is intended for the quantitative determination of immunoglobulin E (IgE) in human serum.

Device Class : 2

Duns Number: 171857493

Premarket Exempt : No

Product Code : DGC

Prescription Use : No

Device Count : 1

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