AccessGUDID - DEVICE: Osteomark NTx Urine (10811877010934)

GUDID

Device Identifier (DI) Information

Brand Name: Osteomark NTx Urine
Version or Model: 9006
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alere Scarborough, Inc.

Primary DI Number: 10811877010934
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 154148498 *Terms of Use

Device Description: An enzyme-linked immunosorbent assay (EIA) for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53636	Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of collagen type I cross-linked N-telopeptides in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JMM	Column Chromatography & Color Development, Hydroxyproline

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e059518-e307-492c-b39f-42ba403a7fbb
Public Version Date: February 27, 2025
Public Version Number: 3
DI Record Publish Date: September 16, 2020