FastPack® IP hCG Diluent Kit (25) 25000036

GUDID 00816467020112

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

QUALIGEN INC.

Total human chorionic gonadotropin (HCG) IVD, kit, chemiluminescent immunoassay
Primary Device ID00816467020112
NIH Device Record Keyebba211b-5190-488d-8b53-525131f9d6f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameFastPack® IP hCG Diluent Kit (25)
Version Model NumberhCG Diluent
Catalog Number25000036
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
GS100816467020112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JHIVisual, Pregnancy Hcg, Prescription Use

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.

00816467020396 - FastPack® IP System2024-10-07
00816467020402 - FastPack® IP System2024-10-07
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

Trademark Results [FastPack]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FASTPACK
FASTPACK
98826028 not registered Live/Pending
Acieta LLC
2024-10-29
FASTPACK
FASTPACK
98443566 not registered Live/Pending
ISSC, Inc.
2024-03-11
FASTPACK
FASTPACK
90474832 not registered Live/Pending
Acieta LLC
2021-01-19
FASTPACK
FASTPACK
90320908 not registered Live/Pending
Squeegee Bros Inc.
2020-11-16
FASTPACK
FASTPACK
88199317 5798966 Live/Registered
KENT PRECISION FOODS GROUP, INC.
2018-11-19
FASTPACK
FASTPACK
85234933 4041065 Live/Registered
VITEC HOLDINGS ITALIA SRL
2011-02-04
FASTPACK
FASTPACK
78487452 3067650 Live/Registered
Target Brands, Inc.
2004-09-22
FASTPACK
FASTPACK
76285908 not registered Dead/Abandoned
Agilera, Inc.
2001-07-17
FASTPACK
FASTPACK
75399007 2412780 Live/Registered
QUALIGEN, INC.
1997-12-02
FASTPACK
FASTPACK
74633834 not registered Dead/Abandoned
Rockport Company, Inc.
1995-02-13
FASTPACK
FASTPACK
73488093 1328557 Live/Registered
Color & Design, Inc.
1984-07-02

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