FDA.reportPublic FDA data

STA® - Fibrinogen 5

Primary DI
13607450006749
Brand
STA® - Fibrinogen 5
Company
DIAGNOSTICA STAGO
Model
00674
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K840211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840211000FIBRI-PREST AUTOMATE HA34Wellcome Diagnostics1984-03-02KQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13607450006749PrimaryGS10
03607450006742Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1360745000674913607450006749
03607450006742036074500067423607450006742

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, kit, clottingA collection of reagents and other associated materials intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen, using a clotting method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
262277122
Device count
12
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607450006766STA® - Coag Control N + ABN006762016-09-15
03607450006773STA® - Coag Control (N + ABN) PLUS006772016-09-15
03607450006780STA® - System Control N + P006782016-09-15
03607450005264STA® - Liatest® Control N + P005262016-09-15
13607450006756STA® - Unicalibrator006752016-09-15
13607450011392Pool Norm011392016-09-15
03607450005400FDP Plasma005402016-09-15
13607450005414FDP Plasma (Latex)005412016-09-15
13607450005513FDP Plasma (Buffer)005512016-09-15
03607450589894STA Compact Max® (with cap piercing option)589892016-09-15
03607450589900STA Compact Max®589902016-09-15
03607450590265STA R Max®590262018-10-30
03607450590272STA R Max® (with cap piercing option)590272018-10-30
13607450009757STA® - Desorb U009752020-09-24
03607450009736STA® - Cleaner Solution009732020-09-29
13607450003601STA® - Owren-Koller003602018-09-24
03607450000030STA Coag Expert®V8871112022-12-09
03607450000047Coag.One server licenseV8867652022-12-09
03607450867657Coag.One server licenseV7867652022-12-09
03607450871111STA Coag Expert®V7871112022-12-09

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
00630414639901Dade CA System BufferSiemens 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
15391521420364TriniCLOT™ Fibrinogen 6 mLTCOAG IRELAND LIMITEDKQJ2016-09-12