← Back to catalogue
Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes FDA UDI
- Generic Name
- Total bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, and 100 Cuvettes. FDA UDI
- Model / Reference
- B2A101 FDA UDI
- Description
- For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, and 100 Cuvettes. FDA UDI
Identifiers
- Catalog Number
- B2A101 FDA UDI
- Primary DI / UDI-DI
- 00816068020030 FDA UDI
- FDA Product Code
- CIG 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
Yes
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, kit, spectrophotometry
Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID
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
- Advanced Instruments, LLC
Sources (1)
- FDA UDI 38686fa3-c865-4a95-b3f8-8f3dfefdd8d8 36 fields · synced Jun 8, 2026