FDA.reportPublic FDA data

C-reactive protein (CRP) IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of C-reactive protein (CRP) in a clinical specimen.
GUDID devices
29
Last updated
2021-03-09 07:50:02

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00816426021679K-ASSAY® hsCRP ControlKAMIYA BIOMEDICAL COMPANY, LLCK180C-2M2021-03-01
03610230009284Yumizen C1200 Level 1 CRPhs ControlHORIBA ABX SAS13000712472020-11-02
03610230009291Yumizen C1200 Level 2 CRPhs ControlHORIBA ABX SAS13000712482020-11-02
00630414971193IMMULITE Systems High Sensitivity CRP CVMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD103736862020-09-24
00842768006425DImension Vista® High Sensitivity CPR Control L (low)Siemens Healthcare Diagnostics Products GmbH104459292020-09-24
00842768006432DImension Vista® High Sensitivity CRP Control H (high)Siemens Healthcare Diagnostics Products GmbH104459302020-09-24
00859110005623ValidateLgc Clinical Diagnostics, Inc.402ab2020-03-02
00859110005647ValidateLgc Clinical Diagnostics, Inc.402re2020-03-02
00859110005654ValidateLgc Clinical Diagnostics, Inc.402vt2020-03-02
00859110005685ValidateLgc Clinical Diagnostics, Inc.404ro2020-03-02
00859110005630ValidateLgc Clinical Diagnostics, Inc.402bc2020-02-15
05055273216226C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV)RANDOX LABORATORIES LIMITEDLV103342020-01-22
05055273216233HIGH SENSITIVITY C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series)RANDOX LABORATORIES LIMITEDLV103352020-01-22
00380740180355AlinityABBOTT LABORATORIES07P56122020-01-13
B085K021M60Audit MicroControls Control LQ hs-CRPAALTO SCIENTIFICK021M-62018-03-27
B085K705M50Audit MicroControls Linearity LQ hs-CRPAALTO SCIENTIFICK705M-52019-02-14
06438115000105QuikRead go® CRP Verification setAidian Oy1452162016-06-01
06438115000112QuikRead go® CRP Control setAidian Oy1452172016-06-01
00847661000914LiquichekBIO-RAD LABORATORIES, INC.2542017-01-16
00847661000921LiquichekBIO-RAD LABORATORIES, INC.2552017-01-16
00847661000938LiquichekBIO-RAD LABORATORIES, INC.2562017-01-16
00847661001768LiquichekBIO-RAD LABORATORIES, INC.255X2017-01-16
00816057021628ASI CRP Control SetARLINGTON SCIENTIFIC, INC.NC-5050012016-07-08
00816426020887K-ASSAY® hs-CRP ControlKAMIYA BIOMEDICAL COMPANY, LLCK80C-4M2016-09-16
00817089020337DiazymeDIAZYME LABORATORIES, INC.DZ135A-CON2016-11-03
00817089020344DiazymeDIAZYME LABORATORIES, INC.DZ135B-CON2016-11-03
00811727011060POINTE SCIENTIFIC CRP Control SetHORIBA INSTRUMENTS INCORPORATEDC7568-CTL2016-08-31
00812137012159CRP Control SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.L1 x 3 x 3mL, L2 x 3 x 3mL2016-10-12
00380740010478ARCHITECTABBOTT LABORATORIES6K26-212016-09-09