FDA.reportPublic FDA data

IMMULITE® Systems PDP CONTROL Pyrilinks-D

Primary DI
00630414953281
Brand
IMMULITE® Systems PDP CONTROL Pyrilinks-D
Company
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
Model
10385243
Catalog number
LPDCM
Device description
Pyrilinks-D - IMMULITE - CTL - 2x2mL
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980833000IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5Diagnostic Products Corp.1998-05-01JMM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414953281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414953281006304149532816304149532810630414953281

GMDN Terms#

Term, Definition table
TermDefinition
Collagen deoxypyridinoline IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of collagen deoxypyridinoline in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711XX@XX.XX
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
296822794
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414965017IMMULITE®/IMMULITE® 1000 Systems SUBS10385394LSUBX2020-09-24
00630414961125IMMULITE® 2000 Systems CEA10380995L2KCE62016-09-24
00630414964980IMMULITE®/IMMULITE® 1000 Systems RPT Turbo Intact PTH10381430LSKPTZ2016-09-24
00630414970110IMMULITE®/IMMULITE® 1000 Systems T4 Total T410381635LKT452016-09-24
00630414972923IMMULITE®2000 Systems Diluent Tube Caps10385211L2ZC2020-09-24
00630414965734IMMULITE® 2000 Systems Allergen Tube Caps10282837L2ATC2020-09-24
00630414965741IMMULITE® 2000 Systems Allergen Tubes10282849L2ATS22020-09-24
00630414973159IMMULITE® 2000 Systems Diluent Tubes10385210L2ZT2020-09-24
00630414974064IMMULITE® 2000 Systems Microsampling Tube Caps10385205LSMC2020-09-24
00630414954547IMMULITE® 2000 Systems Reaction Tubes10385206LRXT2016-09-24
00630414973937IMMULITE® 2000 Systems Microsampling Tubes10385207LMST2016-09-24
00630414982403IMMULITE® 2000 XPi Sample Nesting Cups103741789052882016-09-24
00630414982410IMMULITE® 2000 Xpi Sample Nesting Cups103741799052892016-09-24
00630414961538IMMULITE® 2000 Systems IGF-110381448L2KGF22020-09-24
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)11201759112017592026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)11201761112017612026-02-04
00630414245331Atellica IM aTgII Quality Control (aTgII QC)11201752112017522026-02-04
00630414245348Atellica IM aTgII Master Curve Material (aTgII MCM)11201751112017512026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201758112017582026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)11201760112017602026-02-04

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
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