FDA.reportPublic FDA data

K-ASSAY® Alpha-1 AG Reagent

Primary DI
00816426020146
Brand
K-ASSAY® Alpha-1 AG Reagent
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-021
Catalog number
KAI-021
Device description
For the quantitative determination of human alpha-1 acid glycoprotein (Alpha-1 AG) in serum by immunoturbidimetric assay.
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
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, ControlImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993441000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993441000K-ASSAY ALPHA-1 AGKamiya Biomedical Co.1999-11-24LKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020146008164260201468164260201460816426020146

GMDN Terms#

Term, Definition table
TermDefinition
Alpha-1-acid glycoprotein (orosomucoid) 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 quantitative measurement of alpha-1-acid glycoprotein (orosomucoid) 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
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
04015630919529Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-02-08
04015630928408Tina-quant Alpha 1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2021-01-18
00630414590158ADVIA® Chemistry AAG a1-Acid Glycoprotein ReagentsSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00630414596211Atellica CH AAGSiemens Healthcare Diagnostics Inc.LKL2020-09-24
00842768005985Dimension Vista® a1-Acid Glycoprotein Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHLKL2020-09-24
07613336130162Tina-quant a1-Acid Glycoprotein Gen.2Roche Diagnostics GmbHLKL2020-03-05
00380740156428ARCHITECTABBOTT LABORATORIESLKL2020-03-03
05055273200126ALPHA-1-ACID-GLYCOPROTEIN (AGT)RANDOX LABORATORIES LIMITEDLKL2019-05-31
00380740153809AlinityABBOTT LABORATORIESLKL2019-04-10
00380740054168ARCHITECTABBOTT LABORATORIESLKL2018-07-31
08058056680648alpha 1-Acid GlycoproteinSENTINEL CH. SPALKL2017-05-15
15099590010591AUBECKMAN COULTER IRELAND INC.LKL2016-09-24
B1761230Antiserum to Human Alpha 1 Acid GlycoproteinKENT LABORATORIES INCLKL2016-09-24
05051700016537Human alpha 1 acid glycoprotein Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
05051700017633Optilite Alpha-1-Acid Glycoprotein KitTHE BINDING SITE GROUP LIMITEDLKL2016-09-24
15099590224066IMMAGEBeckman Coulter, Inc.LKL2016-08-24