FDA.reportPublic FDA data

K-ASSAY® Lp(a) Reagent (L)

Primary DI
00816426020122
Brand
K-ASSAY® Lp(a) Reagent (L)
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-017
Catalog number
KAI-017
Device description
For the quantitative determination of human lipoprotein(a) [Lp(a)] 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
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021660000K-ASSAY LP(A) ASSAYKamiya Biomedical Co.2002-07-25DFC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020122008164260201228164260201220816426020122

GMDN Terms#

Term, Definition table
TermDefinition
Lipoprotein A 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 lipoprotein A lipid 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
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
07613336237380Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237397Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
07613336237403Tina-quant Lipoprotein (a) Gen.2 MolarityRoche Diagnostics GmbHDFC2025-05-27
08058056680211Lp(a) UltraSENTINEL CH. SPADFC2024-03-15
05055273204445LIPOPROTEIN (a) CONTROL (Lp (a) CONTROL 3) RANDOX LABORATORIES LIMITEDDFC2022-10-05
00380740170165ARCHITECTABBOTT IRELANDDFC2022-03-16
00380740170158AlinityABBOTT IRELANDDFC2021-05-19
00811727015921Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00811727016225Pointe Lp(a) ReagentHORIBA INSTRUMENTS INCORPORATEDDFC2021-01-30
00380740175146ARCHITECTAbbott GmbHDFC2020-12-15
07613336140833Tina-quant Lipoprotein (a) Gen.2Roche Diagnostics GmbHDFC2020-03-16
07613336133538Tina-quant Apolipoprotein B ver.2Roche Diagnostics GmbHDFC2020-03-05
00380740156435ARCHITECTABBOTT LABORATORIESDFC2020-03-03
00380740154509AlinityAbbott GmbHDFC2019-09-09
00380740153847AlinityABBOTT LABORATORIESDFC2019-05-10
00817302022308CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00817302022315CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay KitCAROLINA LIQUID CHEMISTRIES CORPORATIONDFC2018-09-07
00630414595559Atellica CH Lp(a)Siemens Healthcare Diagnostics Inc.DFC2017-12-21
00817439021069MedTest Dx, Inc. Lp (a)Medtest Dx, Inc.DFC2016-09-27
00817439021090MedTest DX Lipoprotein (a) Calibrator for the BS480Medtest Dx, Inc.DFC2016-09-27
05055273204421Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-26
05051700016841Lipoprotein (a) Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDFC2016-09-24
05055273204384Lp (a)RANDOX LABORATORIES LIMITEDDFC2016-09-24
00842768007552N Latex Lp(a) ReagentSiemens Healthcare Diagnostics Products GmbHDFC2016-09-24
05391516743938Trinity BiotechCLARK LABORATORIES, INC.DFC2016-09-23
04015630917730Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630917754Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630928668Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20
04015630929962Tinaquant Lipoprotein a Gen.2Roche Diagnostics GmbHDFC2016-09-20
04015630930234Tinaquant Apolipoprotein B ver2Roche Diagnostics GmbHDFC2016-09-20