Identity
- Trade Name
- ANTI-PD-1 FDA UDI
- Generic Name
- Programmed death-1 (PD-1) IVD, antibody FDA UDI
- Model / Reference
- AM922-5M FDA UDI
Identifiers
- Catalog Number
- AM922-5M FDA UDI
- Primary DI / UDI-DI
- 00810119672612 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Programmed death-1 (PD-1) 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: Programmed death-1 (PD-1) IVD, antibody
Anti-Pd-1 by Biogenex Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Programmed death-1 (PD-1) IVD, antibody.
- PD-1 — BIOCARE MEDICAL, LLC · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- PD-L1 — BIOCARE MEDICAL, LLC · Class I
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- PD-1 [CAL20] — BIOCARE MEDICAL, LLC · Class I
- PD-L1 — BIOCARE MEDICAL, LLC · Class I
- PD-1 — BIOCARE MEDICAL, LLC · Class I
- Mouse Monoclonal Anti-Human PD-1(MX033) Antibody — Fuzhou Maixin Biotech Co., Ltd. · 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
- Biogenex Laboratories, Inc.
Sources (1)
- FDA UDI 89178e24-9d00-4c0f-8f7e-3f8c4b4e6c69 36 fields · synced Jun 1, 2026