Home › Device types › CIG
Diazo Colorimetry, Bilirubin
FDA product code CIG · Class 2 · Clinical Chemistry
240
Registered devices
399
Adverse events
19
Recalls
235
510(k) clearances
Devices with this code
Direct Bilirubin — Roche Diagnostics GmbHDimension® T4 Calibrator — Siemens Healthcare Diagnostics Inc.GENCHEM™ Total Bilirubin Reagent — GENCHEM INCS8377 REF 944-136 *6 Cleaning solution Met II Solution — Radiometer Medical ApSABX PENTRA BILIRUBIN, TOTAL CP — HORIBA ABX SASDimension® Flex® reagent cartridge URCA — Siemens Healthcare Diagnostics Inc.Piccolo General Chemistry 13 — ABAXIS, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P.Direct Bilirubin — Roche Diagnostics GmbHDimension® Flex® reagent cartridge TBI — Siemens Healthcare Diagnostics Inc.Total Bilirubin — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDBilirubin Direct Gen.2 (Doumas standardization) — Roche Diagnostics GmbHDirect Bilirubin — Roche Diagnostics GmbHBilirubin Total Gen3 — Roche Diagnostics GmbHDIRECT BILIRUBIN-SL Assay — SEKISUI DIAGNOSTICS, LLCStat Profile — NOVA BIOMEDICAL CORPORATIONDimension® TU Calibrator — Siemens Healthcare Diagnostics Inc.Pointe Total Bilirubin Reagent — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT AU-228 — CAROLINA LIQUID CHEMISTRIES CORPORATIONDisposable Waste Container D512 REF 905-590 — Radiometer Medical ApSTotal Bilirubin for the Polychem 180 — Medtest Dx, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-30 | Siemens Healthcare Diagnostics, Inc. | During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an is |
| 2023-08-05 | Ortho-Clinical Diagnostics, INc. | Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not p |
| 2020-07-13 | Ortho-Clinical Diagnostics | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-07-13 | Ortho-Clinical Diagnostics | Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2019-09-11 | Roche Diagnostics Operations, Inc. | Due to low Quality Control recovery and invalid Calibration. |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if pr |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if pr |
| 2018-12-17 | Roche Diagnostics Corporation | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modul |
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