FDA.reportPublic FDA data

K-ASSAY® Apo B Reagent (L)

Primary DI
00816426020177
Brand
K-ASSAY® Apo B Reagent (L)
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-024
Catalog number
KAI-024
Device description
For the quantitative determination of human apolipoprotein B (Apo B) 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
DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DERAlpha-1-Lipoprotein, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993354000K-ASSAY APO BKamiya Biomedical Co.1999-10-28DER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020177008164260201778164260201770816426020177

GMDN Terms#

Term, Definition table
TermDefinition
Apolipoprotein B (Apo B) 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 apolipoprotein B (Apo B) 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
00380740170141ARCHITECTABBOTT IRELANDDER2023-08-10
00380740170134AlinityABBOTT IRELANDDER2021-05-19
00380740175139ARCHITECTAbbott GmbHDER2021-02-18
07613336133521Tina-quant Apolipoprotein A-1 ver.2Roche Diagnostics GmbHDER2020-03-16
00380740153908AlinityAbbott GmbHDER2019-07-03
04015630917723Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630917747AI ver2 Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
04015630928651Tinaquant Apolipoprotein A1 ver2Roche Diagnostics GmbHDER2016-09-20
04015630930227Tinaquant Apolipoprotein AI ver2Roche Diagnostics GmbHDER2016-09-20
00816426020016K-ASSAY® Apo AI ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00816426020030K-ASSAY® Apo B ReagentKAMIYA BIOMEDICAL COMPANY, LLCDER2016-09-16
00817302020878CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT BL-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020885CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020892CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020908CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT AU-633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00817302020915CAROLINA LIQUID CHEMISTRIES CORP.® APO B REAGENT CC633CAROLINA LIQUID CHEMISTRIES CORPORATIONDER2016-09-01
00380740019716ARCHITECTABBOTT LABORATORIESDER2016-06-06