Identity
- Trade Name
- P504S-2X FDA UDI
- Generic Name
- p504s protein IVD, antibody FDA UDI
- Model / Reference
- PP365AA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847627022622 FDA UDI
- FDA Product Code
- MVU FDA UDI
- GMDN Term
- p504s protein IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4020 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: p504s protein IVD, antibody
P504s-2x by Biocare Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as p504s protein IVD, antibody.
- ANTI-P504S / AMACR — Biogenex Laboratories, Inc. · Class I
- Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Mono Rb A-Hu AMACR Cl 13H4 — Agilent Technologies Inc. · Class I
- Rabbit Monoclonal Anti-Human AMACR/P504S(MXR012) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- ANTI-P504S/AMACR — Biogenex Laboratories, Inc. · Class I
- ANTI-P504S/AMACR — Biogenex Laboratories, Inc. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
- Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody — Ventana Medical Systems · 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 82937ddc-07f9-462d-8585-0a2e6060baa0 33 fields · synced Jun 8, 2026