FDA.reportPublic FDA data

Osteomark NTx Serum

Primary DI
10811877010941
Brand
Osteomark NTx Serum
Company
Alere Scarborough, Inc.
Model
9021
Device description
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.
Published
2020-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JMMColumn Chromatography & Color Development, Hydroxyproline

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMMColumn Chromatography & Color Development, HydroxyprolineClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10811877010941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081187701094110811877010941

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
154148498
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10811877010064ISOSTAT® Consumables50C92016-09-05
00811877012214BinaxNOW COVID-19/Flu A&B Combo Self Test200023502026-05-06
00811877012221BinaxNOW COVID-19/Flu A&B Combo Self Test200023512026-05-06
10811877011245WOUNDCHEK™ Bacterial Status360006US2020-05-26
00811877012153ID NOW InstrumentNAT-024R2025-08-01
00811877011477BinaxNOW COVID-19 Antigen Self Test195-1402023-09-05
00811877011118BinaxNOW COVID-19 Antigen Self Test195-1702023-08-11
00811877011729BinaxNOW COVID-19 Antigen Self Test195-1802022-10-03
00811877011408BinaxNOW COVID-19 Antigen Self Test195-1602021-04-21
10811877010934Osteomark NTx Urine90062020-09-16
00811877010050ISOSTAT® Press and Rack50C22016-09-05
00811877010098ISOSTAT® Containment Adapter50C12016-09-03
00811877012030BinaxNOW COVID-19/Flu A&B Combo Self Test20002050 2025-01-30
00811877012047BinaxNOW COVID-19/Flu A&B Combo Self Test20002056 2025-01-30
00811877012054BinaxNOW COVID-19/Flu A&B Combo Self Test200020512025-01-30
00811877012061BinaxNOW COVID-19/Flu A&B Combo Self Test20002057 2025-01-30
00811877012078BinaxNOW COVID-19/Flu A&B Combo Self Test20002052 2025-01-30
00811877012085BinaxNOW COVID-19/Flu A&B Combo Self Test20002058 2025-01-30
00811877012092BinaxNOW COVID-19/Flu A&B 20002054 2025-01-30
00811877012108BinaxNOW COVID-19/Flu A&B Controls20002055 2025-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845533002936NTx UrineZEUS SCIENTIFIC, INC.JMM2026-02-18
00845533002943NTx SerumZEUS SCIENTIFIC, INC.JMM2026-02-18
00845533002004Sebia NTx Serum Test SystemZEUS SCIENTIFIC, INC.JMM2025-06-13
00845533001953ZEUS NTx SerumZEUS SCIENTIFIC, INC.JMM2025-03-21
05060169695986IDS Beta CrossLaps® (CTX-I)IMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2024-01-03
05060169690141Urine CrossLaps® (CTX-I) EIAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2023-06-23
00845533001878ZEUS NTx UrineZEUS SCIENTIFIC, INC.JMM2023-04-18
00845533001861ZEUS NTx SerumZEUS SCIENTIFIC, INC.JMM2023-04-18
07613336171561Elecsys Beta-CrossLaps/serumRoche Diagnostics GmbHJMM2021-10-01
07613336187012Elecsys Beta-CrossLaps/serumRoche Diagnostics GmbHJMM2021-10-01
00630414953281IMMULITE® Systems PDP CONTROL Pyrilinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414954202IMMULITE®/IMMULITE® 1000 Systems DPD Pyrilinks-D Sample DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414961859IMMULITE® 2000 Systems DPD Pyrlinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
00630414964416IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-DSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJMM2020-09-24
10811877010934Osteomark NTx UrineAlere Scarborough, Inc.JMM2020-09-16
10758750000500VITROSORTHO CLINICAL DIAGNOSTICSJMM2020-04-01
30014613333906MicroVueQUIDEL CORPORATIONJMM2018-08-30
30014613333913MicroVueQUIDEL CORPORATIONJMM2018-08-30
04015630940141Elecsys ?-CrossLaps/serumRoche Diagnostics GmbHJMM2017-04-14
04015630914142Elecsys CrossLaps CalSetRoche Diagnostics GmbHJMM2016-09-20
04015630938902Elecsys CrossLapsserum ImmunoassayRoche Diagnostics GmbHJMM2016-09-20
10758750000517VITROSORTHO CLINICAL DIAGNOSTICSJMM2016-08-26
05060169690134Serum CrossLaps® (CTX-I) ELISAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2016-04-01
05060169690158Urine BETA CrossLaps® (CTX-I) ELISAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2016-04-01
05060169690165Alpha CrossLaps® (CTX-I) EIAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2016-04-01
05060169690172Urine CartiLaps ® (CTX-II) EIAIMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2016-04-01
05060169690240IDS-iSYS CTX-I (Crosslaps) IMMUNODIAGNOSTIC SYSTEMS LIMITEDJMM2016-04-01