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 Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample.

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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