Identity
- Trade Name
- BVA100 FDA UDI
- Generic Name
- Blood volume analyser IVD FDA UDI
- Device Name
- An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test. FDA UDI
- Model / Reference
- SC25 MK2 FDA UDI
- Description
- An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B641SC25MK20 FDA UDI
- FDA Product Code
- LXG FDA UDI
- GMDN Term
- Blood volume analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood volume analyser IVD
Bva100 by Daxor Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood volume analyser IVD.
- BVA100 — Daxor Corporation · Class II
- Daxor BVA — Daxor Corporation · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Daxor Corporation
Sources (1)
- FDA UDI e2484550-3ad8-4662-a4a2-f3c37cd19748 34 fields · synced May 30, 2026