Identity
- Trade Name
- BUPRENORPHINE PLUS LOW FDA UDI
- Generic Name
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
- Device Name
- BUPRENORPHINE PLUS LOW FDA UDI
- Model / Reference
- BUP+ LOW U KP FDA UDI
- Description
- BUPRENORPHINE PLUS LOW FDA UDI
Identifiers
- Catalog Number
- BUP+ LOW U KP FDA UDI
- Primary DI / UDI-DI
- B800BUPLOWUKP0 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Multiple-type clinical chemistry analyte profile IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 1 Milliliter FDA UDI
Category: Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LOW is a critical medical device used to control multiple types of clinical chemistry analytes in a clinical specimen, providing a comprehensive multiple-type clinical chemistry analyte profile IVD. With its implantable design and sterilization requirements, this device ensures accurate and reliable results.
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Utak Laboratories, Inc.
Sources (1)
- FDA UDI 6a080c8d-a32a-436f-a2fa-e5949eef80da 37 fields · synced Jul 22, 2026