Identity
- Trade Name
- ANTI-OCT 4 FDA UDI
- Generic Name
- Oct-4 IVD, antibody FDA UDI
- Model / Reference
- AN724-5M FDA UDI
Identifiers
- Catalog Number
- AN724-5M FDA UDI
- Primary DI / UDI-DI
- 00810119672469 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Oct-4 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 6 Milliliter FDA UDI
Category: Oct-4 IVD, antibody
Anti-Oct 4 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oct-4 IVD, antibody.
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human OCT-4 Antibody, EP143 — EPITOMICS, INC. · Class I
- Oct-4 (MRQ-10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- Oct-4 (MRQ-10) Mouse Monoclonal Antibody — CELL MARQUE CORPORATION · Class I
- OCT 4 [EP143 — Biogenex Laboratories, Inc. · Class I
- ANTI- OCT-4 — 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 |
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Manufacturer
- Manufacturer
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 8c370d6a-d5bc-44d3-a8e7-eddfff0eca10 36 fields · synced Jun 1, 2026