FDA.reportPublic FDA data

K-ASSAY® Alpha-1 Microglobulin Reagent

Primary DI
00816426020283
Brand
K-ASSAY® Alpha-1 Microglobulin Reagent
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-056
Catalog number
KAI-056
Device description
For the quantitative determination of human alpha-1 microglobulin in urine, serum and plasma by immunoturbidimetric 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
MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGAAlpha-1 Microglobulin, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020283008164260202838164260202830816426020283

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-microglobulin IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of alpha-1-microglobulin 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
04048474051001α1-Microglobulin ELISADRG Instruments Gesellschaft mit beschränkter HaftungMGA2023-09-01
00840239051004a1-Microglobulin ELISADRG International IncMGA2023-08-25
06971674868064BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674868439BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869306BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869313BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869320BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
06971674869337BIOBASEBiobase Biodustry(Shandong)Co., Ltd.MGA2023-07-24
00816426020603K-ASSAY® Urine Alpha-1 Microglobulin CalibratorKAMIYA BIOMEDICAL COMPANY, LLCMGA2016-09-16
00816426020610K-ASSAY® Serum / Plasma Alpha-1 Microglobulin CalibratorKAMIYA BIOMEDICAL COMPANY, LLCMGA2016-09-16
15099590180140IMMAGEBeckman Coulter, Inc.MGA2016-08-24
00889024198517NAZimmer, Inc.MGA2016-05-24