Identity
- Trade Name
- Synchron FDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- ENZYMATIC BILIRUBIN REAGENT FDA UDI
- Model / Reference
- 683802 FDA UDI
- Description
- ENZYMATIC BILIRUBIN REAGENT FDA UDI
Identifiers
- Catalog Number
- 683802 FDA UDI
- Primary DI / UDI-DI
- 15099590222642 FDA UDI
- FDA Product Code
- JFM FDA UDI
- GMDN Term
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Total bilirubin IVD, kit, spectrophotometry
Synchron by Beckman Coulter, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total bilirubin IVD, kit, spectrophotometry.
- POINTE SCIENTIFIC Bilirubin, Total — POINTE SCIENTIFIC, INC. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® TBIL RGT. KIT BL-228 — Carolina Liquid Chemistries Corp. · Class II
- ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents — Siemens Healthcare Diagnostics · Class I
- Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P. · Class II
- Bilirubin Total Gen.3 — Roche Diagnostics Corp. · Class II
- TOTAL BILIRUBIN-SL-X — Sekisui Diagnostics, LLC · Class II
- Alinity — ABBOTT IRELAND · Class I
- Direct Bilirubin — Roche Diagnostics Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI 6eb5817b-bdf3-4bfb-bbbb-f3d9b59c3ee5 34 fields · synced Jun 8, 2026