QUALIGEN INC.

Address:2042 CORTE DEL NOGAL,CARLSBAD,CA,92011,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

Calibrator, Secondary (JIT) (4) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Calibrator, Multi-Analyte Mixture (JIX) (1) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1) Visual, Pregnancy Hcg, Prescription Use (JHI) (1)

Premarket Exempt

No Yes

Clear

FastPack® IP System - 00816467020006 Catalog Number : 08000043, 08000043-R, 08000043-X

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJQ

Prescription Use : Yes

Device Count : 1

Calibrator Kit - PSA - 00816467020020 Catalog Number : 25000002

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Calibrator Kit - Testosterone - 00816467020044 Catalog Number : 25000014

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Calibrator Kit – Free T4 - 00816467020068 Catalog Number : 25000016

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JIX

Prescription Use : Yes

Device Count : 1

Method Verification Kit - PSA - 00816467020075 Catalog Number : 25000017

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Calibrator Kit – TSH - 00816467020099 Catalog Number : 25000024

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

Calibrator Kit – hCG - 00816467020105 Catalog Number : 25000035

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JIT

Prescription Use : Yes

Device Count : 1

FastPack® IP hCG Diluent Kit (25) - 00816467020112 Catalog Number : 25000036

Device Description : Used to dilute the sample if the test result reads outside the assay range. Max

Device Class : 2

Duns Number: 959103565

Premarket Exempt : No

Product Code : JHI

Prescription Use : Yes

Device Count : 1

FastPack® Control Kit - 00816467020136 Catalog Number : 25000056

Device Description : Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Method Verification Kit - Vitamin D - 00816467020143 Catalog Number : 25000064, 25000074

Device Class : 1

Duns Number: 959103565

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

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