FDA.reportPublic FDA data

Multiple heavy metal 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 one or multiple heavy metals in a clinical specimen.
GUDID devices
39
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B80001696000010METALS LEVEL 1UTAK LABORATORIES, INC.MET T 1 WB UK2022-07-27
B80001696000020METALS LEVEL 2UTAK LABORATORIES, INC.MET T 2 WB UK2022-08-10
B80001696000030METALS LEVEL 1UTAK LABORATORIES, INC.MET T 1 DP UK2022-08-10
B80001696000040METALS LEVEL 2UTAK LABORATORIES, INC.MET T 2 DP UK2022-08-10
B80010095200040STOCK 3UTAK LABORATORIES, INC.STK 3 WB V2 BD 222022-05-09
B80010095200050STOCK 4UTAK LABORATORIES, INC.STK 4 WB V2 BD 222022-05-09
B800121100High Range Urine MetalsUTAK LABORATORIES, INC.121102020-04-15
B800121110Normal Range Urine MetalsUTAK LABORATORIES, INC.121112020-04-15
B800445210Metals Level 1UTAK LABORATORIES, INC.445212020-04-15
B800445220Metals Level 2UTAK LABORATORIES, INC.445222020-04-15
B800445230Metals Level 3UTAK LABORATORIES, INC.445232020-04-15
B800668150High Range Trace Elements UTAK LABORATORIES, INC.668152020-04-15
B800668160Normal Range Trace Elements UTAK LABORATORIES, INC.668162020-04-15
B800TRACELSFUK0TRACE ELEMENTS LOWUTAK LABORATORIES, INC.TRACE L S F UK2023-01-19
B80010095200030STOCK 2UTAK LABORATORIES, INC.STK 2 WB V2 BD 222022-05-09
B80010095200041STOCK 3UTAK LABORATORIES, INC.STK 3 WB V2 BD 222022-05-09
B80010095200051STOCK 4UTAK LABORATORIES, INC.STK 4 WB V2 BD 222022-05-09
B80001696000021METALS LEVEL 2UTAK LABORATORIES, INC.MET T 2 WB UK2022-08-10
B80001696000031METALS LEVEL 1UTAK LABORATORIES, INC.MET T 1 DP UK2022-08-10
B80001696000041METALS LEVEL 2UTAK LABORATORIES, INC.MET T 2 DP UK2022-08-10
B80001696000011METALS LEVEL 1UTAK LABORATORIES, INC.MET T 1 WB UK2022-07-27
B80010095200020STOCK 1UTAK LABORATORIES, INC.STK 1 WB V2 BD 222022-05-09
B800100952000230STOCK 2UTAK LABORATORIES, INC.STK 2 WB V2 BD 222022-05-09
B800100952000241STOCK 3UTAK LABORATORIES, INC.STK 3 WB V2 BD 222022-05-09
B800100952000251STOCK 4UTAK LABORATORIES, INC.STK 4 WB V2 BD 222022-05-09
B800121105High Range Urine MetalsUTAK LABORATORIES, INC.121102020-04-15
B800121115Normal Range Urine MetalsUTAK LABORATORIES, INC.121112020-04-15
B800445215Metals Level 1UTAK LABORATORIES, INC.445212020-04-15
B800445225Metals Level 2UTAK LABORATORIES, INC.445222020-04-15
B800445235Metals Level 3UTAK LABORATORIES, INC.445232020-04-15
B800668155High Range Trace Elements UTAK LABORATORIES, INC.668152020-04-15
B800668165Normal Range Trace Elements UTAK LABORATORIES, INC.668162020-04-15
00847661000280LyphochekBIO-RAD LABORATORIES, INC.4002017-01-09
00847661000297LyphochekBIO-RAD LABORATORIES, INC.4052017-01-09
00847661001683LyphochekBIO-RAD LABORATORIES, INC.5272017-01-09
00847661001690LyphochekBIO-RAD LABORATORIES, INC.5282017-01-09
00847661001706LyphochekBIO-RAD LABORATORIES, INC.5292017-01-09
00847661001843LyphochekBIO-RAD LABORATORIES, INC.528X2017-01-09
00847661004073LyphochekBIO-RAD LABORATORIES, INC.402X2017-01-09