Manufacturer Profile

QUALIGEN INC. Registered Devices

Listing registered devices, PMA filings, and compliance records for QUALIGEN INC..

gudid RoHS Compliant FastPack System ID: IP System

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gudid RoHS Compliant 7-chamber FastPack System ID: Pro System

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gudid Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. ID: PSA Controls

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gudid Method Verification Kit - Vitamin D ID: Vit. D Verifier

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gudid Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG ID: Multi-Analyte Controls

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gudid Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. ID: hCG Diluent

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gudid Calibrator Kit hCG ID: hCG Cal

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gudid Calibrator Kit TSH ID: TSH Cal

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gudid Method Verification Kit - PSA ID: TPSA Verifier

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gudid Calibrator Kit Free T4 ID: FT4 Cal

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gudid Calibrator Kit - Testosterone ID: Testo Cal

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gudid Calibrator Kit - PSA ID: TPSA Cal

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gudid 90 Test Kit SARS-CoV-2 IgG Immunoassay ID: SARS-CoV-2 IgG Immunoassay

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gudid 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control ID: FastPack IP SHBG 60 Immunoassay

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gudid 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control ID: Vit. D Immunoassay

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gudid 30 Test Ported hCG Immunoassay Kit ID: hCG Immunoassay

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gudid 50 Test Non-Ported Testo Immunoassay Kit ID: Testo Immunoassay

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gudid 50 Test Non-Ported TPSA Immunoassay Kit ID: TPSA Immunoassay

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gudid 90 Test Ported Testo Immunoassay Kit ID: Testo Immunoassay

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gudid 90 Test Ported TPSA Immunoassay Kit ID: TPSA Immunoassay

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gudid 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls ID: FastPack IP SHBG 30 Immunoassay

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gudid 30 Test Ported TSH Immunoassay Kit ID: TSH Immunoassay

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gudid 30 Test Ported FT4 Immunoassay Kit ID: FT4 Immunoassay

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gudid 30 Test Ported Testo Immunoassay Kit ID: Testo Immunoassay

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gudid 30 Test Ported TPSA Immunoassay Kit ID: TPSA Immunoassay

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