FDA.reportPublic FDA data

K-ASSAY® Cystatin C Reagent (L)

Primary DI
00816426020320
Brand
K-ASSAY® Cystatin C Reagent (L)
Company
KAMIYA BIOMEDICAL COMPANY, LLC
Model
KAI-074
Catalog number
KAI-074
Device description
For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin 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
NDYTest, Cystatin C

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDYTest, Cystatin CClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093137000K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKamiya Biomedical Co.2010-09-28NDY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816426020320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816426020320008164260203208164260203200816426020320

GMDN Terms#

Term, Definition table
TermDefinition
Cystatin C IVD, reagentA reagent which is 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 cystatin C protein 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
08058056685414Cystatin CSENTINEL CH. SPANDY2025-09-16
08058056685421Cystatin CSENTINEL CH. SPANDY2025-09-16
07613336133644Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2020-03-05
00630414595573Atellica™ CH CysCSiemens Healthcare Diagnostics Inc.NDY2019-02-09
00630414224916ADVIA Chemistry Cystatin C_2 AssaySiemens Healthcare Diagnostics Inc.NDY2018-09-24
00630414236919Atellica CH CYSC_2Siemens Healthcare Diagnostics Inc.NDY2018-09-24
00630414167824N Latex Cystatin CSiemens Healthcare Diagnostics Products GmbHNDY2017-06-20
07090038460078Gentian Cystatin C Control Kit (2 x 1mL)Gentian ASNDY2016-11-24
07090038460085Gentian Cystatin C Control Kit (2 x 5mL)Gentian ASNDY2016-11-24
07090038460092Gentian Cystatin C CalibratorGentian ASNDY2016-11-24
07090038460108Gentian Cystatin C Calibrator KitGentian ASNDY2016-11-24
07090038460115Gentian Cystatin C Single Use Control LowGentian ASNDY2016-11-18
07090038460122Gentian Cystatin C Single Use Control HighGentian ASNDY2016-11-18
14560189212173ST AIA-PACK Cystatin CTOSOH CORPORATIONNDY2016-09-24
17090038460013Gentian Cystatin C Reagent for the Beckman Coulter AU Systems (1x300)Gentian ASNDY2016-09-24
17090038460020Gentian Cystatin C Control Kit (2 x 1mL)Gentian ASNDY2016-09-24
17090038460037Gentian Cystatin C Calibrator KitGentian ASNDY2016-09-24
17090038460051Gentian Cystatin C Reagent Beckman Coulter UDR KitGentian ASNDY2016-09-24
04560189212206ST AIA-PACK Cyctatin C Sample Dilting SolutionTOSOH CORPORATIONNDY2016-09-24
05051700011624Human Cystatin C Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDNDY2016-09-24
05051700017909Optilite Cystatin C KitTHE BINDING SITE GROUP LIMITEDNDY2016-09-24
07090038460061Gentian Cystatin C Reagent KitGentian ASNDY2016-09-24
00842768006104DImension Vista® Cystatin C Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHNDY2016-09-24
00842768007934N Latex Cystatin CSiemens Healthcare Diagnostics Products GmbHNDY2016-09-24
00630414557915ADVIA® Chemistry CYSC Cystatin-C ReagentsSiemens Healthcare Diagnostics Inc.NDY2016-09-24
04015630932382Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-22
04015630932399Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-20
04015630932405Tina-quant Cystatin C Gen.2Roche Diagnostics GmbHNDY2016-09-20
05055273208665CYSCRANDOX LABORATORIES LIMITEDNDY2016-09-16
05700572013853DakoAGILENT TECHNOLOGIES SINGAPORE PTE LTDNDY2016-09-16