FDA.reportPublic FDA data

ZEUS NTx Urine

Primary DI
00845533001878
Brand
ZEUS NTx Urine
Company
ZEUS SCIENTIFIC, INC.
Model
NTx9006
Device description
An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.
Published
2023-04-18
Public version status
New
Distribution status
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
00845533001878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845533001878008455330018788455330018780845533001878

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
080953946
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845533003551Legionella pneumophila (Group 1-6)FA15001FA150012026-05-26
00845533003568Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgGFA9151GFA9151G2026-05-26
00845533003575Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgMFA9151MFA9151M2026-05-26
00845533003483Striated Muscle (Rat)5848RL5848RL2026-05-15
00845533003490Alegria Flash PR3CL28141CL281412026-05-15
00845533003506Alegria Flash PR3 Control KitCL28141CKCL28141CK2026-05-15
00845533003513Alegria Flash MPO CL28131CL281312026-05-15
00845533003520Alegria Flash MPO Control KitCL28131CKCL28131CK2026-05-15
00845533003537Alegria Flash GBM CL28151CL281512026-05-15
00845533003544Alegria Flash GBM Control KitCL28151CKCL28151CK2026-05-15
00845533003476Fluorescent Treponemal Antibody-Absorption Titratable (FTA-ABS TT)FA7001TFA7001T2026-04-15
00845533002851Anti-SARS-CoV-2 IgGSM9Z7901GSM9Z7901G2026-04-01
00845533002868Anti-SARS-CoV-2 TotalSM9Z7901SM9Z79012026-04-01
00845533003100Anti-dsDNA2Z2881G2Z2881G2026-04-01
00845533003117Anti-dsDNASM2Z2881GSM2Z2881G2026-04-01
00845533003124Anti-EBV EA IgG9Z9481G9Z9481G2026-04-01
00845533003131Anti-EBV EA IgGSM9Z9481GSM9Z9481G2026-04-01
00845533003148ENA Screen2Z2851G2Z2851G2026-04-01
00845533003155ENA ScreenSM2Z2851GSM2Z2851G2026-04-01
00845533003162Anti-Gliadin IgA2Z61001A2Z61001A2026-04-01

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
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
10811877010941Osteomark NTx SerumAlere 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