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Glypican-3 (1G12) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 261M-90Model 261M-9X series
Identity
- Trade Name
- Glypican-3 (1G12) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Glypican-3 IVD, antibody FDA UDI
- Device Name
- Glypican-3 (1G12) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 261M-90 EUDAMEDFDA UDI261M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683107156 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831261M-9CU EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Glypican-3 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
Category: Glypican-3 IVD, antibody
Glypican-3 (1G12) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glypican-3 IVD, antibody.
- Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- ANTI-GLYPICAN-3 — Biogenex Laboratories, Inc. · Class I
- Glypican-3 — BIOCARE MEDICAL, LLC · Class I
- ANTI-GLYPICAN-3 — Biogenex Laboratories, Inc. · Class I
- Mouse Monoclonal Anti-Human Glypican-3(MAXIM001) Antibody — Fuzhou Maixin Biotech Co., Ltd. · Class I
- Glypican-3 — BIOCARE MEDICAL, LLC · Class I
- ANTI-GLYPICAN-3 — Biogenex Laboratories, Inc. · Class I
- Glypican-3 — BIOCARE MEDICAL, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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 (2)
- FDA UDI 4838e3d6-6425-4717-83e0-6a128f1c4de2 33 fields · synced Oct 6, 2026
- EUDAMED 00b88a7e-289e-48a0-a93b-c0c06f30af1c 61 fields · synced Oct 6, 2026