Pantex Universal 16465-260

GUDID 00850039602689

Pantex Sample Collection Device single

Pantex

Total cortisol IVD, kit, enzyme immunoassay (EIA) Total cortisol IVD, kit, enzyme immunoassay (EIA) Total cortisol IVD, kit, enzyme immunoassay (EIA) Total cortisol IVD, kit, enzyme immunoassay (EIA) Total cortisol IVD, kit, enzyme immunoassay (EIA) Total cortisol IVD, kit, enzyme immunoassay (EIA) Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Oral/respiratory tract specimen container IVD, no additive/medium Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD
Primary Device ID00850039602689
NIH Device Record Key3edfbdb3-5e3f-4481-9289-149c838f21bf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePantex Universal
Version Model Number1 Universal
Catalog Number16465-260
Company DUNS072296809
Company NamePantex
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 Usefalse
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

Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com
Phone1-310-828-7423
Emailinfo@pantexba.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039602689 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection
NHGEnzyme Immunoassay, Cortisol, Salivary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-31
Device Publish Date2022-05-23

On-Brand Devices [Pantex Universal]

00850039602689Pantex Sample Collection Device single
10850039602273Stopping Solution EIA 1 - 15mL
10850039602266Color Development Reagent EIA 1 - 15mL
1085003960215010x Wash Solution EIA 1 - 50mL
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