FDA.reportPublic FDA data

Multiple lipid analyte IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple lipid analytes to generate a lipid profile of a clinical specimen.
GUDID devices
39
Last updated
2022-10-13 08:01:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05055273204155LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)RANDOX LABORATORIES LIMITEDLE26612022-10-05
05055273204162LIPID CONTROL - LEVEL 2 (LPD CONTROL 2)RANDOX LABORATORIES LIMITEDLE26622022-10-05
05055273204179LIPID CONTROL - LEVEL 3 (LPD CONTROL 3)RANDOX LABORATORIES LIMITEDLE26632022-10-05
05055273204186LIPID CONTROL - LEVEL 1 (LPD CONTROL 1)RANDOX LABORATORIES LIMITEDLE26682022-10-05
05055273204193LIPID CONTROL - LEVEL 2 (LPD CONTROL 2)RANDOX LABORATORIES LIMITEDLE26692022-10-05
05055273204209LIPID CONTROL - LEVEL 3 (LPD CONTROL 3)RANDOX LABORATORIES LIMITEDLE26702022-10-05
00847661001249LiquichekBIO-RAD LABORATORIES, INC.6412020-09-14
00847661001256LiquichekBIO-RAD LABORATORIES, INC.6422020-09-14
00847661002109LiquichekBIO-RAD LABORATORIES, INC.640X2020-09-14
05055273216455LIPID LINEARITY VERIFIERS (For Beckman Coulter AU Systems) (Lipid LinVer - BC)RANDOX LABORATORIES LIMITEDLV103642020-04-17
00859110005753ValidateLgc Clinical Diagnostics, Inc.501au2020-03-02
00859110005760ValidateLgc Clinical Diagnostics, Inc.501bc2020-03-02
00859110005777ValidateLgc Clinical Diagnostics, Inc.501db2020-03-02
00859110005784ValidateLgc Clinical Diagnostics, Inc.501ro2020-03-02
00859110005791ValidateLgc Clinical Diagnostics, Inc.501sa2020-03-02
00859110005807ValidateLgc Clinical Diagnostics, Inc.501vt2020-03-02
00859110005746ValidateLgc Clinical Diagnostics, Inc.501ab2020-02-15
05055273215199LIQUID FROZEN LIPID CONTROL - LEVEL 1 (LIQ LPD CONTROL 1)RANDOX LABORATORIES LIMITEDLE101742019-06-03
05055273215205LIQUID FROZEN LIPID CONTROL - LEVEL 2 (LIQ LPD CONTROL 2)RANDOX LABORATORIES LIMITEDLE101752019-06-03
05055273215212LIQUID FROZEN LIPID CONTROL - LEVEL 3 (LIQ LPD CONTROL 3)RANDOX LABORATORIES LIMITEDLE101762019-06-03
B085K826M50Audit MicroControls Linearity FD Lipids Beckman AUAALTO SCIENTIFICK826M-52019-04-17
15099590221270VigilBeckman Coulter, Inc.4699052016-08-24
15099590222901VigilBeckman Coulter, Inc.4659822016-08-24
15099590222918VigilBeckman Coulter, Inc.4659812016-08-24
15099590222925VigilBeckman Coulter, Inc.4659802016-08-24
B085K709M50Audit MicroControls Linearity FD LipidsAALTO SCIENTIFICK709M-52018-03-27
B085K882M50Audit MicroControls Linearity FD Lipids for Roche SystemsAALTO SCIENTIFICK882M-52018-03-27
00857969006433Alfa WassermannALFA WASSERMANN, INC.C2-872017-10-10
00816426020931K-ASSAY® Liquid Lipid ControlKAMIYA BIOMEDICAL COMPANY, LLCK110C-2M2016-09-16
00817089020023DiazymeDIAZYME LABORATORIES, INC.DZ138A-CON2016-11-03
00817238010271LIQUID QC LIPID CONTROL LEVEL CLINIQA CORPORATION915012018-08-23
00817238010288LIQUID QC LIPID CONTROL LEVEL 2 CLINIQA CORPORATION915022018-08-23
00817238010295LIQUID QC LIPID CONTROL Bi-level CLINIQA CORPORATION915052018-08-23
00817439020000Direct Lipid Control SetMedtest Dx, Inc.30002016-09-27
00817439020017Direct Lipid Control L1Medtest Dx, Inc.30012016-09-27
00817439020024Direct Lipid Control L2Medtest Dx, Inc.30022016-09-27
00817439020031Direct Lipid Control L3Medtest Dx, Inc.30032016-09-27
00817439021045MedTest DX, Inc. Lipid ControlsMedtest Dx, Inc.LIPC4802016-09-30
00811727011848Pointe Scientfic, Inc. Lipid ControlsHORIBA INSTRUMENTS INCORPORATEDL7580-182016-08-31