Identity
- Trade Name
- Advanced Instruments BR2 Sample Diluent FDA UDI
- Generic Name
- Conjugated (direct) bilirubin IVD, kit, spectrophotometry FDA UDI
- Device Name
- 30mL bottle of Diluent FDA UDI
- Model / Reference
- B2A101D FDA UDI
- Description
- 30mL bottle of Diluent FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816068020078 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Conjugated (direct) 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
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: Conjugated (direct) bilirubin IVD, kit, spectrophotometry
Advanced Instruments BR2 Sample Diluent by Advanced Instruments, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Conjugated (direct) bilirubin IVD, kit, spectrophotometry.
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- ENVOY 500 DIRECT BILIRUBIN REAGENT KIT — VITALSCIENTIFIC
- DIRECT BILIRUBIN-SL Assay — Sekisui Diagnostics, LLC · Class II
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- DBIL Reagent Kit — Medica Corp. · Class II
- Thermo Scientific — Fisher Diagnostics · 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 1122164f-ce99-4c7e-96b4-b522a20b158e 33 fields · synced Jun 8, 2026