25 OH Vitamin D Total (90') ELISA EIA-6087

GUDID 00840239060877

The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

DRG International Inc

Multiple form 25-hydroxy Vitamin D IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239060877
NIH Device Record Key117edbab-405f-4fa3-83df-a8b370aaca26
Commercial Distribution StatusIn Commercial Distribution
Brand Name25 OH Vitamin D Total (90') ELISA
Version Model NumberEIA-6087
Catalog NumberEIA-6087
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
GS100840239060877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRGSystem, Test, Vitamin D

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