FDA.reportPublic FDA data

Dade CA System Buffer

Primary DI
00630414639901
Brand
Dade CA System Buffer
Company
Siemens Healthcare Diagnostics Products GmbH
Model
10873915
Catalog number
10873915
Device description
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQJSYSTEM, FIBRINOGEN DETERMINATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQJSystem, Fibrinogen DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050928000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050928000DADE THROMBIN REAGENTDade Behring, Inc.2005-06-29KQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00630414639901PrimaryGS10
00842768019845Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414639901006304146399016304146399010630414639901
00842768019845008427680198458427680198450842768019845

GMDN Terms#

Term, Definition table
TermDefinition
Buffered sample diluent IVDA buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)242-3233CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
388240673
Device count
8
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842768013317N Latex ADNase B10446658OWTI112020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridge10445906K70642020-09-24
00842768012167N Cuvette Segments for BN II10446520OVIB312017-11-15
00842768012198Behring Coagulation Cup10446526OVIS312017-10-31
00842768012297N Evaporation Caps for Control Vials (2.5 mL)10446534OVLC212017-10-31
00842768012303N Evaporation Caps for Reagent Vials (5 ml)10446535OVLC312017-10-31
00842768013065Enzygnost® TAT micro10446632OWMG152016-09-24
00842768014246N Reaction Buffer10446455OUMS652016-09-24
00842768017742Washing Solution for Coagulation Analyzers10446684OWZC392016-09-24
00842768024887BFT II Analyzer10458677OVKF0322016-09-24
00630414639703Control Plasma P10873891108738912024-02-19
00630414639772Standard Human Plasma10873907108739072024-03-25
00630414640167Dade Ci-Trol Coagulation Control Level 110873842108738422024-03-25
00630414640259Dade Ci-Trol Heparin Control, Low10873833108738332024-03-25
00630414640280Dade Ci-Trol Coagulation Control Level 210873843108738432024-03-25
00630414640365Dade Ci-Trol Heparin Control, High10873834108738342024-03-25
00630414640426Dade Ci-Trol Coagulation Control Level 310873844108738442024-03-25
00630414640747Control Plasma N 10873874108738742024-02-19
00842768003899Dade® Ci-Trol® Heparin Control, Low10445715B4224-502016-09-24
00842768003905Dade® Ci-Trol® Heparin Control, High10445716B4224-602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414639734Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639741Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640150Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640266Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640273Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640372Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018541Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018503Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019845Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019524Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019517Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019494Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019500Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640532Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
G0561009890Calcium ChlorideBio/Data CorporationKQJ2023-08-30
00859394006040FibrotekR 2 DIAGNOSTICS, INC.KQJ2016-11-15
05051700010726Human Fibrinogen BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDKQJ2016-09-24
00842768003936Dade® Data-Fi® Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003943Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003950Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003981Dade® Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768007170Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017865Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017872Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768039416Dade® CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
08426950451976HemosIL Low Fibrinogen ControlINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950087618HemosIL Fibrinogen-C XLINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950478676HemosIL Fibrinogen-CINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
13607450006749STA® - Fibrinogen 5DIAGNOSTICA STAGOKQJ2016-09-15
15391521420364TriniCLOT™ Fibrinogen 6 mLTCOAG IRELAND LIMITEDKQJ2016-09-12