Salivary Progesterone ELISA SLV-2931

GUDID 00840239029317

Enzyme immunoassay for the in vitro diagnostic quantitative measurement of active free progesterone (a female hormone) in saliva.

DRG International Inc

Progesterone IVD, kit, enzyme immunoassay (EIA) Progesterone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239029317
NIH Device Record Key04d5cf15-8eea-4499-80f4-521dd2f20f50
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalivary Progesterone ELISA
Version Model NumberSLV-2931
Catalog NumberSLV-2931
Company DUNS075150847
Company NameDRG International Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100840239029317 [Primary]

FDA Product Code

JLSRadioimmunoassay, Progesterone

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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