FDA.reportPublic FDA data

K-ASSAY® Factor XIII Calibrator

Primary DI
00816426020764
Brand
K-ASSAY® Factor XIII Calibrator
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-206C
Catalog number
KAI-206C
Device description
For the calibration of the K-ASSAY® Factor XIII assay.
Published
2016-09-16
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
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
00816426020764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020764008164260207648164260207640816426020764

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor XIII IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of coagulation factor XIII 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
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
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
00816426020924K-ASSAY® Coagulation ControlKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16
00816426021013K-ASSAY® Coagulation ControlKAMIYA BIOMEDICAL COMPANY, LLCDBT2016-09-16