Crosslaps Serum ELISA EIA-2124

GUDID 00840239021243

The Crosslaps Serum ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type I collagen in human serum and plasma.

DRG International Inc

Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked C-telopeptide IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239021243
NIH Device Record Keyf2a4cff9-a233-4b05-a648-737b6ed6c093
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrosslaps Serum ELISA
Version Model NumberEIA-2124
Catalog NumberEIA-2124
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 Batchfalse
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

Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
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
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
GS100840239021243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-31
Device Publish Date2023-08-23

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