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Glypican-3 (1G12) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 261M-96Model 261M-9X seriesRef 261M-98
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-96 EUDAMEDFDA UDI261M-98 EUDAMEDFDA UDI261M-9X series EUDAMED261M-95 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683131359 EUDAMEDFDA UDI00841683131373 EUDAMEDFDA UDI00841683131342 FDA 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 (5)
- FDA UDI 44cfcd3e-ce9e-4913-a4b0-910747923bbd 33 fields · synced Jul 23, 2026
- FDA UDI c0571256-887e-4d99-b271-41b2da0b557c 33 fields · synced May 30, 2026
- FDA UDI 846f61d2-3b57-4b1f-bb84-b188bc397adf 33 fields · synced May 30, 2026
- EUDAMED 64855032-b6b6-4ec9-93cc-a3db154652c2 61 fields · synced Jul 21, 2026
- EUDAMED 438520ac-5ec5-42e7-9ec1-664ce4a6fb94 61 fields · synced Jul 23, 2026