FDA.reportPublic FDA data

Total bilirubin IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of total bilirubin in a clinical specimen.
GUDID devices
33
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00896863002288Pediatric Bilirubin Control Level 1&2 Set 2x3mLQUANTIMETRIX CORPORATION1330-012018-09-26
00896863002295Pediatric Bilirubin Control Level 1 Set 3x3mLQUANTIMETRIX CORPORATION1331-312018-09-26
00896863002301Pediatric Bilirubin Control Level 2 Set 3x3mLQUANTIMETRIX CORPORATION1332-312018-09-26
B085K742M50Audit MicroControls Linearity FD BilirubinAALTO SCIENTIFICK742M-52025-04-10
B085K866M50Audit MicroControls Linearity FD General Chemistry Panel 3 for Alfa WassermannAALTO SCIENTIFICK866M-52025-03-06
B085K919M50Audit MicroControls Linearity FLQ General Chemistry Panel 3 for Roche SystemsAALTO SCIENTIFICK919M-52023-06-06
05055273216820LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) RANDOX LABORATORIES LIMITEDBR104422022-09-20
05055273216837LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) RANDOX LABORATORIES LIMITEDBR104432022-09-20
B085K701MSUPP0Audit MicroControls Linearity FD Bilirubin SupplementAALTO SCIENTIFICK701M-SUPP2022-07-12
05055273216479BILIRUBIN LINEARITY VERIFIER (For Roche Systems) (BILIRUBIN LIN VER ROCHE)RANDOX LABORATORIES LIMITEDLV103562020-04-17
05055273200706BILIRUBIN ELEVATED SERUM (BIL CONTROL H)RANDOX LABORATORIES LIMITEDBE4542019-06-03
05055273215175LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1)RANDOX LABORATORIES LIMITEDBR101722019-06-03
05055273215182LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2)RANDOX LABORATORIES LIMITEDBR101732019-06-03
B085K825M50Audit MicroControls Linearity FD Bilirubin Beckman AUAALTO SCIENTIFICK825M-52019-04-17
15099590223014UltimateBeckman Coulter, Inc.6677402016-08-24
15099590223021UltimateBeckman Coulter, Inc.6677302016-08-24
15099590223038UltimateBeckman Coulter, Inc.6677202016-08-24
15099590228705UltimateBeckman Coulter, Inc.6677102016-08-24
B085K886M50Audit MicroControls Linearity FD Bilirubin for Roche SystemsAALTO SCIENTIFICK886M-52018-03-27
00884883003835MAS® Bilirubin Liquid Assayed Bilirubin ControlMicrogenics CorporationBC1012017-04-26
00884883003842MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics CorporationBC1022017-04-26
00884883003859MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics CorporationBC1032017-04-26
00884883003866MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics CorporationBC-S12017-04-26
00884883004610MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics Corporation100144302017-09-28
00884883004627MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics Corporation100144312017-09-28
00884883004634MAS Bilirubin Liquid Assayed Bilirubin ControlMicrogenics Corporation100144322017-09-28
00817274021934JAS DiagnosticsDREW SCIENTIFIC, INC.BIN2-BUL2016-09-12
00817274021941JAS DiagnosticsDREW SCIENTIFIC, INC.DG-TBN2/BID2-1252016-09-12
00817274021958JAS DiagnosticsDREW SCIENTIFIC, INC.TBN2-1252016-09-12
00817274021965JAS DiagnosticsDREW SCIENTIFIC, INC.TBN2-125U2016-09-12
00817274021972JAS DiagnosticsDREW SCIENTIFIC, INC.TBN2-BUL2016-09-12
00817274021989JAS DiagnosticsDREW SCIENTIFIC, INC.XL-TBN2-402016-09-12
00817274022528JAS DiagnosticsDREW SCIENTIFIC, INC.TBN2-1L2017-04-10