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MUC4 (8G7) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 406M-16Model 406M-1X seriesRef 406M-15Ref 406M-18Ref 406M-14
Identity
- Trade Name
- MUC4 (8G7) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Mucin IVD, antibody FDA UDI
- Device Name
- MUC4 (8G7) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 406M-14 EUDAMEDFDA UDI406M-18 EUDAMEDFDA UDI406M-16 EUDAMEDFDA UDI406M-15 EUDAMEDFDA UDI406M-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683141464 EUDAMEDFDA UDI00841683141501 EUDAMEDFDA UDI00841683141488 EUDAMEDFDA UDI00841683141471 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831406M-1C7 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Mucin 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: Mucin IVD, antibody
MUC4 (8G7) 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 Mucin IVD, antibody.
- Rabbit Monoclonal Anti-Human MUC1 Antibody, EP85 — EPITOMICS, INC. · Class I
- Genemed® — Sakura Finetek USA, Inc · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human MUC4 Antibody, EP256 — EPITOMICS, INC. · Class I
- BOND™ — Leica Biosystems Newcastle, Limited · Class I
- Rabbit Monoclonal Anti-Human MUC1 Antibody, EP85 — EPITOMICS, INC. · Class I
- Anti-MUC1 (H23) Mouse Monoclonal Primary Antibody — Ventana Medical Systems · 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 (8)
- FDA UDI dcf83cc0-e3c5-42f9-b171-2b73d0ea90bd 33 fields · synced Jul 31, 2026
- FDA UDI 55afed5f-5548-42f6-98a6-17c6cb3adc69 33 fields · synced May 30, 2026
- FDA UDI 3984bc23-1a00-4d77-9015-c610a8d74dcc 33 fields · synced May 30, 2026
- FDA UDI a950c30c-85cc-44e0-b0b5-339801d9d0df 33 fields · synced May 30, 2026
- EUDAMED 5f661a30-a421-4e43-a944-990a88e89d81 61 fields · synced Jul 9, 2026
- EUDAMED 54c87cb1-d7c2-4e75-a4e0-9742f0ec9c0b 61 fields · synced Jul 16, 2026
- EUDAMED adda3132-680c-44f7-aaac-2733102fa80a 61 fields · synced Jul 30, 2026
- EUDAMED 2f0540f8-17a7-45b8-9114-a9ec4985f6d8 61 fields · synced Jul 31, 2026