FDA.reportPublic FDA data

Urine BETA CrossLaps® (CTX-I) ELISA

Primary DI
05060169690158
Brand
Urine BETA CrossLaps® (CTX-I) ELISA
Company
IMMUNODIAGNOSTIC SYSTEMS LIMITED
Model
AC-05F1
Published
2016-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
05060169690158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060169690158050601696901585060169690158

GMDN Terms#

Term, Definition table
TermDefinition
Collagen type I cross-linked C-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 C-telopeptides in a clinical specimen, using an enzyme immunoassay (EIA) method. Collagen type I cross-linked C-telopeptide is a biomarker for bone turnover and elevated levels are associated with conditions of increased bone lysis (e.g., multiple myeloma, osteolytic metastases, and rheumatoid arthritis).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Store upon receipt at 2 to 8 degrees celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401915190660info.uk@idsplc.com

Regulatory Flags#

DUNS number
494268600
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060169690721IDS-iSYS Total TestosteroneN/AIS-50002026-04-17
05060169690875IDS-iSYS Total Testosterone Control SetN/AIS-50302026-04-17
05060169691063IDS-iSYS Total Testosterone Calibration VerifiersN/AIS-50352026-04-17
05060169691230IDS-iSYS Free TestosteroneIS-53002025-11-03
05060169691247IDS-iSYS Free Testosterone Control SetIS-53302025-11-03
05060169691254IDS-iSYS Free Testosterone Calibration VerifiersIS-53352025-11-03
05060169693968IDS-i10IS-8104002023-06-27
05060169691223IDS-iSYS Multi Discipline Automated SystemIS-3104002016-04-01
05060169695986IDS Beta CrossLaps® (CTX-I)IS-3000N2024-01-03
05060169696013IDS Beta CrossLaps® (CTX-I) Calibrator SetIS-3020N2024-01-03
05060169696051IDS Beta CrossLaps® (CTX-I) Control SetIS-3030N2024-01-03
05060169696457IDS ACTH IIIS-4500NG2023-08-23
05060169696495IDS ACTH II Calibrator SetIS-4520NG2023-08-23
05060169696532IDS ACTH II Control SetIS-4530NG2023-08-23
05060169691148IDS-iSYS SDSpeed CalcIS-SDSCALC2023-06-27
05060169691261IDS AndrostenedioneIS-54002023-06-27
05060169691278IDS Androstenedione Control SetIS-54302023-06-27
05060169692305IDS-iSYS D-Sorb SolutionIS-DS2002023-06-27
05060169693913IDS Top Cap SetIS-CAP3002023-06-27
05060169696099IDS Androstenedione Calibrator SetIS-54202023-06-27

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
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
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