FDA.reportPublic FDA data

Multiple human hormone IVD, control

Definition
A material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of multiple human hormones in a clinical specimen.
GUDID devices
22
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B085K927M50Audit MicroControls Linearity FLQ Fertility for Roche SystemsAALTO SCIENTIFICK927M-52019-07-23
B800202070CATECHOLAMINES LEVEL 1UTAK LABORATORIES, INC.202072020-07-24
B800202080CATECHOLAMINES LEVEL 2UTAK LABORATORIES, INC.202082020-07-24
B800202090CATECHOLAMINES LEVEL 3UTAK LABORATORIES, INC.202092020-07-24
B085K818M50Audit MicroControls Linearity FLQ Fertility Siemens AtellicaAALTO SCIENTIFICK818M-52023-06-15
00850011135396ValidateLgc Clinical Diagnostics, Inc.608mm2022-03-11
00850011135402ValidateLgc Clinical Diagnostics, Inc.510mm2022-02-09
00850011135440ValidateLgc Clinical Diagnostics, Inc.508ro2022-02-09
00847661000983LyphochekBIO-RAD LABORATORIES, INC.4802020-09-14
00847661000990LyphochekBIO-RAD LABORATORIES, INC.4812020-09-14
00847661001003LyphochekBIO-RAD LABORATORIES, INC.4822020-09-14
00847661001010LyphochekBIO-RAD LABORATORIES, INC.4832020-09-14
00847661001065LyphochekBIO-RAD LABORATORIES, INC.6002020-09-14
00847661001829LyphochekBIO-RAD LABORATORIES, INC.480X2020-09-14
00847661001904LyphochekBIO-RAD LABORATORIES, INC.600X2020-09-14
B800202075CATECHOLAMINES LEVEL 1UTAK LABORATORIES, INC.202072020-07-24
B800202085CATECHOLAMINES LEVEL 2UTAK LABORATORIES, INC.202082020-07-24
B800202095CATECHOLAMINES LEVEL 3UTAK LABORATORIES, INC.202092020-07-24
B085K947M50Audit MicroControls Linearity FLQ Fertility for Abbott SystemsAALTO SCIENTIFICK947M-52020-07-01
07613336164358PreciControl Maternal CareRoche Diagnostics GmbH087400621602020-03-05
00850212007072Fertility Control FUJIREBIO DIAGNOSTICS, INC.21301622020-12-07
B085K808M50Audit MicroControls Linearity FD Fertility Siemens AtellicaAALTO SCIENTIFICK808M-52018-03-27