Calibrator Kit – hCG 25000035

GUDID 00816467020105

QUALIGEN INC.

Total human chorionic gonadotropin (HCG) IVD, calibrator
Primary Device ID00816467020105
NIH Device Record Keyf5d68fdb-a83d-4345-a3bf-7f11eb28aa4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalibrator Kit – hCG
Version Model NumberhCG Cal
Catalog Number25000035
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
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
Phone1-877-770-6127
Emailsystemsupport@qualigeninc.com
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816467020105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JITCalibrator, Secondary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by QUALIGEN INC.

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10816467020126 - FastPack® IP hCG Kit (30)2023-07-06 30 Test Ported hCG Immunoassay Kit
10816467020034 - FastPack® Testo Kit (50)2023-05-03 50 Test Non-Ported Testo Immunoassay Kit
00816467020372 - FastPack® Pro System2020-08-13 RoHS Compliant 7-chamber FastPack System
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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