FDA.reportPublic FDA data

Elecsys CrossLapsserum Immunoassay

Primary DI
04015630938902
Brand
Elecsys CrossLapsserum Immunoassay
Company
Roche Diagnostics GmbH
Model
11972308160
Catalog number
11972308160
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993706000ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAYRoche Diagnostics Corp.2000-07-24JMM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630938902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630938902040156309389024015630938902

GMDN Terms#

Term, Definition table
TermDefinition
Collagen type I cross-linked C-telopeptide IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of collagen type I cross-linked C-telopeptides and/or metabolites [e.g., beta-isomerized C-terminal telopeptide of type I collagen (beta-CTx)] in a clinical specimen, using a chemiluminescent immunoassay method. Collagen type I cross-linked C-telopeptide and metabolites are typically used to aid in the diagnosis of conditions associated with elevated bone lysis/resorption (e.g., multiple myeloma, osteolytic metastasis, osteoporosis, rheumatoid arthritis).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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07613336218341Elecsys CA 19-909755608190097556081902026-06-01
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07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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