Identity
- Trade Name
- Topoisomerase II alpha FDA UDI
- Generic Name
- Topoisomerase IIa IVD, antibody FDA UDI
- Model / Reference
- ACI3045A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627002785 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Topoisomerase IIa IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Topoisomerase IIa IVD, antibody
Topoisomerase II alpha by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Topoisomerase IIa IVD, antibody.
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
- Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- CONFIRM anti-Topoisomerase II [JS5B4] Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · Class I
- Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mouse Monoclonal Anti-Human Topoisomerase II Alpha(TOPOIIα)(MX108) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Novocastra™ — Leica Biosystems Newcastle, Limited · Class I
- ANTI-TOPOISOMERASE II ALPHA — Biogenex Laboratories, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biocare Medical, Llc
Sources (1)
- FDA UDI b623d298-6cf4-47d8-a321-0863ec759575 33 fields · synced Jun 1, 2026