Identity
- Trade Name
- T BIL FDA UDI
- Generic Name
- Total bilirubin IVD, reagent FDA UDI
- Device Name
- The TBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of total bilirubin in serum or plasma. FDA UDI
- Model / Reference
- BR2802 FDA UDI
- Description
- The TBIL method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of total bilirubin in serum or plasma. FDA UDI
Identifiers
- Catalog Number
- BR2802 FDA UDI
- Primary DI / UDI-DI
- 05055273200829 FDA UDI
- 510(k) Number
- K973995 FDA UDI
- FDA Product Code
- GIG FDA UDI
- GMDN Term
- Total bilirubin IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7500 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
No
FDA UDI
Category: Total bilirubin IVD, reagent
T Bil by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 41da359d-ff52-4d86-94a5-db274fbfd377 37 fields · synced Jun 8, 2026