NDY

Product Code: NDY


Products Classified as NDY

632Test, Cystatin CCreatinine Test System.

Total Product Life Cycle (TPLC) Devices

632Test, Cystatin CCreatinine Test System.

FDA Consensus Standards

Test, Cystatin C [32368]21 CFR §862.1225 🔎

Pre-market Notifications for NDY

K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.
K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH
K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (RDO)
K141143COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SETRoche Diagnostics
K111664DIAZYME CYSTATIN C POC TEST KITDIAZYME LABORATORIES
K093960ST AIA-PACK CYSTATIN C, MODEL 025217Tosoh BioScience, Inc.
K093680DIAZYME CYSTATIN C ASSAYDIAZYME LABORATORIES
K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLKAMIYA BIOMEDICAL CO.
K083906ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487SIEMENS HEALTHCARE DIAGNOSTICS
K081875GENTIAN CYSTATIN C IMMUNOASSAYGENTIAN AS
K080811TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SETROCHE DIAGNOSTICS CORP.
K080662GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATORGENZYME CORPORATION
K080384HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSERTHE BINDING SITE, LTD.
K072270DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)DIAZYME LABORATORIES
K072166CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZERTHE BINDING SITE

Global Unique Device Identification Database

00630414557915TEST, CYSTATIN C
00630414236919TEST, CYSTATIN C
00630414224916TEST, CYSTATIN C
00630414167824TEST, CYSTATIN C
00817302020069TEST, CYSTATIN C
00816426020320Test, Cystatin C
00816426020313Test, Cystatin C
00842768007934TEST, CYSTATIN C
00842768006104TEST, CYSTATIN C
07090038460122Test, Cystatin C
07090038460115Test, Cystatin C
07090038460108Test, Cystatin C
07090038460092Test, Cystatin C
07090038460085Test, Cystatin C
07090038460078Test, Cystatin C

Maude Adverse Events

CYSTATIN C TQ GEN.2ROCHE DIAGNOSTICS2019-10-17
CYSTATIN C TQ GEN.2ROCHE DIAGNOSTICS2017-10-04
CYSTATIN C TQ GEN.2ROCHE DIAGNOSTICS2017-07-10
CYSTATIN C TQ GEN.2ROCHE DIAGNOSTICS2016-04-14
COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAYROCHE DIAGNOSTICS2015-09-29
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