FDA.reportPublic FDA data

K-ASSAY® Fibrinogen Calibrator

Primary DI
00816426021082
Brand
K-ASSAY® Fibrinogen Calibrator
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-136C
Catalog number
KAI-136C
Device description
For the calibration of the K-ASSAY® Fibrinogen assay.
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GISTest, Fibrinogen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GISTest, FibrinogenHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993482000K-ASSAY FIBRINOGENKamiya Biomedical Co.1999-12-06GIS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426021082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426021082008164260210828164260210820816426021082

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of fibrinogen (factor I) 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
206-575-8068diagnostics@k-assay.com

Regulatory Flags#

DUNS number
197934250
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816426020894K-ASSAY® Plasma ControlK81C-6MK81C-6M2016-09-16
00816426020924K-ASSAY® Coagulation ControlK104C-10MK104C-10M2016-09-16
00816426021013K-ASSAY® Coagulation ControlK204C-10MK204C-10M2016-09-16
00816426021099K-ASSAY® Factor XIII ControlK135C-10MK135C-10M2017-02-09
00816426021129K-ASSAY® Factor XIII ControlK204C-10MK204C-10M2017-02-09
00816426021266K-ASSAY® D-Dimer ControlK92C-2MK92C-2M2018-05-30
00816426021273K-ASSAY® D-Dimer ControlK92C-4MK92C-4M2018-05-30
00816426021600K-ASSAY® Cystatin C CalibratorKAI-200CKAI-200C2026-04-16
00816426021617K-ASSAY® Cystatin C ControlK200C-2MK200C-2M2026-04-16
00816426021594K-ASSAY® UIBC ReagentKAI-305KAI-3052026-03-13
00816426021549K-ASSAY® CRP Reagent (Ver.2)KAI-375KAI-3752026-02-27
00816426021556K-ASSAY® CRP Calibrator (Ver.2)KAI-376CKAI-376C2026-02-27
00816426020146K-ASSAY® Alpha-1 AG ReagentKAI-021KAI-0212016-09-16
00816426020375K-ASSAY® Total IgE ReagentKAI-092KAI-0922016-09-16
00816426020672K-ASSAY® Total IgE CalibratorKAI-093CKAI-093C2016-09-16
00816426021389K-ASSAY® Total IgE ControlK94C-4MK94C-4M2019-01-25
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAI-400CKAI-400C2024-04-17
00816426020641K-ASSAY® CRP (3) Calibrator FKAI-086CKAI-086C2016-09-16
00816426020269K-ASSAY® Fructosamine Reagent + Calibrator (L)KAI-050KAI-0502016-09-16
00816426021402K-ASSAY® UIBC Reagent (L)KAI-301KAI-3012019-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816426021075K-ASSAY® Fibrinogen ReagentKAMIYA BIOMEDICAL COMPANY, LLCGIS2017-01-13
10859394006191FIB CalibratorR 2 DIAGNOSTICS, INC.GIS2016-11-15
00859394006040FibrotekR 2 DIAGNOSTICS, INC.GIS2016-11-15
00817089020672DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020689DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
00817089020696DiazymeDIAZYME LABORATORIES, INC.GIS2016-11-03
08426950573494HemosIL Q.F.A. Thrombin (Bovine) - 5 mLINSTRUMENTATION LABORATORY COMPANYGIS2016-09-23
08426950573500HemosIL Q.F.A. Thrombin (Bovine) - 2 mLINSTRUMENTATION LABORATORY COMPANYGIS2016-09-23
00845275000580Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000597Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000627Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000825Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000849Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00845275000856Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIS2016-09-16
00816426020214K-ASSAY® Fibrinogen Reagent + CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020351K-ASSAY® Fibrinogen Reagent (L)KAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16
00816426020658K-ASSAY® Fibrinogen CalibratorKAMIYA BIOMEDICAL COMPANY, LLCGIS2016-09-16