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Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution FDA UDI
- Generic Name
- Total bilirubin IVD, calibrator FDA UDI
- Device Name
- 3mL bottle of 5 mg/dL Bilirubin Equivalent Solution FDA UDI
- Model / Reference
- B2A101L FDA UDI
- Description
- 3mL bottle of 5 mg/dL Bilirubin Equivalent Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816068020092 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Total bilirubin IVD, calibrator 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
No
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, calibrator
Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Total bilirubin IVD, calibrator.
- ARCHITECT — Abbott · Class II
- Alinity — Abbott · Class II
- Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution — Advanced Instruments, LLC · 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 |
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Manufacturer
- Manufacturer
- Advanced Instruments, LLC
Sources (1)
- FDA UDI e14635b5-4592-4113-be73-ff3f8a513ea3 34 fields · synced Jun 8, 2026