Salivary Testosterone ELISA SLV-303

GUDID 00840239030139

The Salivary Testosterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

DRG International Inc

Total testosterone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239030139
NIH Device Record Keyad7c1d96-a7a0-4db9-bde2-d388c43650f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalivary Testosterone ELISA
Version Model NumberSLV-3013
Catalog NumberSLV-303
Company DUNS075150847
Company NameDRG International 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 973-564-7555
Emailcorpoffice@drg-international.com
Phone1 973-564-7555
Emailcorpoffice@drg-international.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840239030139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-26

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