Osteomark NTx Serum

GUDID 10811877010941

A test for the quantitative measure of cross-linked N-telopeptides of Type I Collagen (NTx) in human serum as an indicator of bone resorption.

Alere Scarborough, Inc.

Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA) Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
Primary Device ID10811877010941
NIH Device Record Key154b3a86-2f8d-4ecc-8105-f9ec3f5142e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteomark NTx Serum
Version Model Number9021
Company DUNS154148498
Company NameAlere Scarborough, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110811877010941 [Primary]

FDA Product Code

JMMColumn Chromatography & Color Development, Hydroxyproline

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-24
Device Publish Date2020-09-16

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