FDA.reportPublic FDA data

K-ASSAY® Complement C4 Reagent

Primary DI
00816426020085
Brand
K-ASSAY® Complement C4 Reagent
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-010
Catalog number
KAI-010
Device description
For the quantitative determination of human 4th complement component (Complement C4) in serum 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
DBIComplement C4, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DBIComplement C4, Antigen, Antiserum, ControlImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993481000K-ASSAY C4Kamiya Biomedical Co.1999-11-29DBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020085008164260200858164260200850816426020085

GMDN Terms#

Term, Definition table
TermDefinition
Complement components C4/C4c 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 complement cascade components C4 and/or C4c 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
00380740170196AlinityABBOTT IRELANDDBI2021-05-13
00380740170202ARCHITECTABBOTT IRELANDDBI2021-03-19
00380740175160ARCHITECTAbbott GmbHDBI2020-11-06
07613336133606Tina-quant Complement C4 Ver.2Roche Diagnostics GmbHDBI2020-03-05
00380740150679AlinityAbbott GmbHDBI2019-06-27
00630414595658Atellica CH C4Siemens Healthcare Diagnostics Inc.DBI2017-12-27
15099590010577AUBeckman Coulter, Inc.DBI2016-09-24
B1761090Antiserum to Human C-4 (b1e)KENT LABORATORIES INCDBI2016-09-24
B1761092Anti Human Complement C4 (b1e) FITCKENT LABORATORIES INCDBI2016-09-24
05051700015585Human C4 Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
05051700017602Optilite C4 KitTHE BINDING SITE GROUP LIMITEDDBI2016-09-24
00842768005237Dimension® Flex® reagent cartridge C4Siemens Healthcare Diagnostics Inc.DBI2016-09-24
00842768006067Dimension Vista® C4 Complement Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009693N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00842768009709N Antiserum to Human C4Siemens Healthcare Diagnostics Products GmbHDBI2016-09-24
00630414517742ADVIA® Chemistry C4 Complement C4 ReagentsSiemens Healthcare Diagnostics Inc.DBI2016-09-24
04015630910267Tinaquant C4Roche Diagnostics GmbHDBI2016-09-20
04015630917716Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
04015630928460Tinaquant Complement C4 ver2Roche Diagnostics GmbHDBI2016-09-20
05055273201628C4RANDOX LABORATORIES LIMITEDDBI2016-09-16
05700572002420Poly Rb A-Hu C4c Complement/FITCAGILENT TECHNOLOGIES SINGAPORE PTE LTDDBI2016-09-16
00817302020939CAROLINA LIQUID CHEMISTRIES CORP.® C4 Complement C4 CC635CAROLINA LIQUID CHEMISTRIES CORPORATIONDBI2016-09-01
15099590229726SynchronBeckman Coulter, Inc.DBI2016-08-24
15099590230449IMMAGEBeckman Coulter, Inc.DBI2016-08-24
10758750006854VITROSORTHO-CLINICAL DIAGNOSTICS, INC.DBI2016-08-23
00380740019747ARCHITECTABBOTT LABORATORIESDBI2016-06-06