ZEUS NTx Serum XJ9021

GUDID 00845533001953

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

ZEUS SCIENTIFIC, INC.

Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00845533001953
NIH Device Record Keyd75816fb-b00e-43f1-bcce-227ec2a96016
Commercial Distribution StatusIn Commercial Distribution
Brand NameZEUS NTx Serum
Version Model NumberNTx9021
Catalog NumberXJ9021
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
GS100845533001953 [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 Date2025-03-31
Device Publish Date2025-03-21

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