FDA.reportPublic FDA data

K-ASSAY® Coagulation Control

Primary DI
00816426020924
Brand
K-ASSAY® Coagulation Control
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
K104C-10M
Catalog number
K104C-10M
Device description
For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DBTFactor Xiii A, S, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBTFactor Xiii A, S, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020924008164260209248164260209240816426020924

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation factor IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components 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
Premarket exempt
true
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
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
00816426020177K-ASSAY® Apo B Reagent (L)KAI-024KAI-0242016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816426021099K-ASSAY® Factor XIII ControlKAMIYA BIOMEDICAL COMPANY, LLCDBT2017-02-09
00816426021129K-ASSAY® Factor XIII ControlKAMIYA BIOMEDICAL COMPANY, LLCDBT2017-02-09
08426950358725HemosIL Factor XIII AntigenINSTRUMENTATION LABORATORY COMPANYDBT2016-09-23
00816426020467K-ASSAY® Factor XIII ReagentKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16
00816426020535K-ASSAY® Factor XIII ReagentKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16
00816426020719K-ASSAY® Factor XIII CalibratorKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16
00816426020764K-ASSAY® Factor XIII CalibratorKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16
00816426021013K-ASSAY® Coagulation ControlKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16