Method Verification Kit - PSA 25000017

GUDID 00816467020075

QUALIGEN INC.

Total prostate specific antigen (tPSA) IVD, control
Primary Device ID00816467020075
NIH Device Record Keyc8b8bd96-7b4c-4649-a172-e8262559a6c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMethod Verification Kit - PSA
Version Model NumberTPSA Verifier
Catalog Number25000017
Company DUNS959103565
Company NameQUALIGEN INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816467020075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-09-16

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00816467020389 - FastPack SARS-CoV-2 IgG2020-08-13 90 Test Kit SARS-CoV-2 IgG Immunoassay
10816467020010 - FastPack® Total PSA Kit (50)2020-02-06 50 Test Non-Ported TPSA Immunoassay Kit
20816467020017 - FastPack® IP Total PSA Kit (30)2020-02-06 30 Test Ported TPSA Immunoassay Kit

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