Identity
- Trade Name
- ANTI-SYNAPTOPHYSIN FDA UDI
- Generic Name
- Synaptophysin IVD, antibody FDA UDI
- Model / Reference
- AN857-5M FDA UDI
Identifiers
- Catalog Number
- AN857-5M FDA UDI
- Primary DI / UDI-DI
- 00810119671264 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Synaptophysin 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Synaptophysin IVD, antibody
Anti-Synaptophysin by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synaptophysin IVD, antibody.
- Synaptophysin Rabbit Polyclonal Antibody — CELL MARQUE CORPORATION · Class I
- Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Synaptophysin (EP158) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
- Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158 — EPITOMICS, INC. · Class I
- Tinto Synaptophysin (RBT-Synaptophysin) — BIO SB, INC. · Class I
- Mono Mo A-Hu Synaptophysin Cl DAK-SYNAP — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class I
- Synaptophysin (RBT-Synaptophysin) — BIO SB, INC. · Class I
- Rabbit Monoclonal Anti-Human Synaptophysin Antibody, EP158 — EPITOMICS, 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 |
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Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 8c25b0ff-1b77-4463-a4b6-f3a81e53cd2f 36 fields · synced May 30, 2026