FDA.reportPublic FDA data

D-Dimer Control I/II

Primary DI
04015630904204
Brand
D-Dimer Control I/II
Company
Roche Diagnostics GmbH
Model
11556509216
Catalog number
11556509216
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
DAPFIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DAPFibrinogen And Fibrin Split Products, Antigen, Antiserum, ControlHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002706000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002706000ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA; ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON HITACHIRoche Diagnostics Corp.2001-03-16DAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630904204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630904204040156309042044015630904204

GMDN Terms#

Term, Definition table
TermDefinition
D-dimer IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.

Storage And Handling#

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

Regulatory Flags#

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

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04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
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20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
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07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870023878D-Dimer AccuLite CLIA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023885D-Dimer AccuLite CLIA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00816870023892D-Dimer AccuBind ELISA Test System - 192 WellsMONOBIND, INC.DAP2024-09-13
00816870023908D-Dimer AccuBind ELISA Test System - 96 WellsMONOBIND, INC.DAP2024-09-13
00630414639666INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00842768019265INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640181INNOVANCE D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640488INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
00630414640501INNOVANCE D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2024-03-25
05056080501666Thrombo-Wellcotest Glycine SalineREMEL EUROPE LIMITEDDAP2021-07-21
08426951391615HemosIL D-Dimer HS 500INSTRUMENTATION LABORATORY COMPANYDAP2019-06-10
00895160002502Fluoro-CheckTM D-DimerNANO-DITECH CORPORATIONDAP2019-05-24
30014613337959TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338000TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
30014613338017TriageQUIDEL CARDIOVASCULAR INC.DAP2018-11-01
00817089020542DiazymeDIAZYME LABORATORIES, INC.DAP2016-11-03
00893038002326Alere Triage®Alere San Diego, Inc.DAP2016-09-26
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00899722002740Alere Triage®Alere San Diego, Inc.DAP2016-09-26
B1761070Antiserum to Human FibrinogenKENT LABORATORIES INCDAP2016-09-24
05056080500041NAREMEL EUROPE LIMITEDDAP2016-09-24
05056080500058NAREMEL EUROPE LIMITEDDAP2016-09-24
00842768003967Dade® DIMERTEST® Latex AssaySiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768003974Dade® DIMERTEST® Latex BeadsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768004575Acute Care™ D-DIMER CalPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768004582Stratus® CS Acute Care™ DDMR DilPakSiemens Healthcare Diagnostics Inc.DAP2016-09-24
00842768022814INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768022821INNOVANCE® D-DimerSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768023668INNOVANCE® D-Dimer ControlsSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24
00842768027611INNOVANCE® D-Dimer Sample DiluentSiemens Healthcare Diagnostics Products GmbHDAP2016-09-24