Identity
- Trade Name
- Advanced Instruments BR2 Bilirubin Stat-Analyzer FDA UDI
- Generic Name
- Bilirubinometer IVD FDA UDI
- Device Name
- For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. FDA UDI
- Model / Reference
- BR2 FDA UDI
- Description
- For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. FDA UDI
Identifiers
- Catalog Number
- BR2 FDA UDI
- Primary DI / UDI-DI
- 00816068020054 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Bilirubinometer IVD 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bilirubinometer IVD
Advanced Instruments BR2 Bilirubin Stat-Analyzer by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Advanced Instruments, LLC
Sources (1)
- FDA UDI cc267749-dfaa-49b3-8db7-90fb37150049 35 fields · synced Jun 8, 2026