QUALIGEN INC.

Address:2042 CORTE DEL NOGAL,CARLSBAD,CA,92011,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, Testosterones And Dihydrotestosterone (CDZ) (3) Calibrator, Secondary (JIT) (1) Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers (LTJ) (1) Radioimmunoassay, Free Thyroxine (CEC) (1) Radioimmunoassay, Thyroid-Stimulating Hormone (JLW) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

FastPack® IP Testo Kit (30) - 20816467020031 Catalog Number : 25000041

Device Description : 30 Test Ported Testo Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 30

FastPack® IP Free T4 Kit (30) - 20816467020055 Catalog Number : 25000043

Device Description : 30 Test Ported FT4 Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : CEC

Prescription Use : Yes

Device Count : 30

FastPack® IP TSH Kit (30) - 20816467020086 Catalog Number : 25000042

Device Description : 30 Test Ported TSH Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : JLW

Prescription Use : Yes

Device Count : 30

FastPack® IP SHBG - 20816467020345 Catalog Number : 25000081

Device Description : 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJX, JIT, CDZ

Prescription Use : Yes

Device Count : 30

FastPack® IP Total PSA Kit (90) - 30816467020014 Catalog Number : 25000057

Device Description : 90 Test Ported TPSA Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : LTJ

Prescription Use : Yes

Device Count : 90

FastPack® IP Testo Kit (90) - 30816467020038 Catalog Number : 25000058

Device Description : 90 Test Ported Testo Immunoassay Kit

Device Class :

Duns Number: 959103565

Premarket Exempt : No

Product Code : CDZ

Prescription Use : Yes

Device Count : 90

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