FDA.reportPublic FDA data

K-ASSAY® RF / ASO Liquid Control

Primary DI
00816426020993
Brand
K-ASSAY® RF / ASO Liquid Control
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
K125C-2M
Catalog number
K125C-2M
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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020993008164260209938164260209930816426020993

GMDN Terms#

Term, Definition table
TermDefinition
Plasma protein IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of plasma proteins 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816426021532K-ASSAY® RF Calibrator (Ver.2)KAI-400CKAI-400C2024-04-17
00816426021679K-ASSAY® hsCRP ControlK180C-2MK180C-2M2021-03-01
00816426021631K-ASSAY® Apo AI / B ControlK310C-2MK310C-2M2020-12-28
00816426021648K-ASSAY® Apo AI / B ControlK310C-4MK310C-4M2020-12-28
00816426020894K-ASSAY® Plasma ControlK81C-6MK81C-6M2016-09-16
00816426021129K-ASSAY® Factor XIII ControlK204C-10MK204C-10M2017-02-09
00816426021396K-ASSAY® UIBC ReagentKAI-300KAI-3002019-04-09
00816426021402K-ASSAY® UIBC Reagent (L)KAI-301KAI-3012019-04-09
00816426021419K-ASSAY® UIBC CalibratorKAI-302CKAI-302C2019-04-09
00816426021358K-ASSAY® Insulin ControlK73C-2MK73C-2M2019-01-25
00816426021365K-ASSAY® Insulin ControlK73C-4MK73C-4M2019-01-25
00816426021372K-ASSAY® Total IgE ControlK94C-2MK94C-2M2019-01-25
00816426021389K-ASSAY® Total IgE ControlK94C-4MK94C-4M2019-01-25
00816426021280K-ASSAY® Beta-2 Microglobulin ReagentKAI-280KAI-2802018-12-19
00816426021297K-ASSAY® Beta-2 Microglobulin Serum / Plasma CalibratorKAI-281CKAI-281C2018-12-19
00816426021303K-ASSAY® Beta-2 Microglobulin Urine CalibratorKAI-282CKAI-282C2018-12-19
00816426021310K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma ControlK283C-2MK283C-2M2018-12-19

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