PD-1 (NAT105) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- PD-1 (NAT105) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Programmed death-1 (PD-1) IVD, antibody FDA UDI
- Device Name
- PD-1 (NAT105) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 315M-96 EUDAMEDFDA UDI760-4895 EUDAMEDFDA UDI315M-94 EUDAMEDFDA UDI315M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683135326 EUDAMEDFDA UDI00841683101543 EUDAMEDFDA UDI00841683135302 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831315M-9CE EUDAMED008416831760-48953K EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Programmed death-1 (PD-1) IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Programmed death-1 (PD-1) IVD, antibody
PD-1 (NAT105) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Programmed death-1 (PD-1) IVD, antibody.
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (6)
- FDA UDI 14cba77e-28a1-4918-8630-16450a595057 33 fields · synced Jul 30, 2026
- FDA UDI 9f53f2c8-562f-453e-b2e0-486bef15bdee 33 fields · synced May 30, 2026
- FDA UDI 2a21cc01-335e-4582-bfd6-4fc7d103257e 33 fields · synced May 30, 2026
- EUDAMED 4a45f723-34f1-45d9-8544-0e83af5f5b5f 61 fields · synced Jul 15, 2026
- EUDAMED 2fe41141-e53e-454f-bc72-bc96618ed380 61 fields · synced Jul 18, 2026
- EUDAMED 5d12581f-60e6-43ee-b94e-ad7c27d91c57 61 fields · synced Jul 30, 2026