NTx Urine

GUDID 00845533002936

An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.

ZEUS SCIENTIFIC, INC.

Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00845533002936
NIH Device Record Key6ee936ed-3310-458f-ab31-585eb0cf14f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNTx Urine
Version Model NumberNTx9006
Company DUNS080953946
Company NameZEUS SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100845533002936 [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 Date2026-02-26
Device Publish Date2026-02-18

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00845533002936 - NTx Urine2026-02-26An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.
00845533002936 - NTx Urine2026-02-26 An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen

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