c-Myc (EP121) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- c-Myc (EP121) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- c-MYC proto-oncogene protein IVD, antibody FDA UDI
- Device Name
- c-Myc (EP121) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 395R-14 EUDAMEDFDA UDI395R-16 EUDAMEDFDA UDI395R-15 EUDAMEDFDA UDI395R-17 EUDAMEDFDA UDI395R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683121824 EUDAMEDFDA UDI00841683121848 EUDAMEDFDA UDI00841683121831 EUDAMEDFDA UDI00841683140702 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831395R-1FF EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- c-MYC proto-oncogene protein 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: c-MYC proto-oncogene protein IVD, antibody
c-Myc (EP121) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as c-MYC proto-oncogene protein IVD, antibody.
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- c-Myc (RBT-CMYC) — BIO SB, INC. · Class I
- Anti-C-myc-Protein — Biogenex Laboratories, Inc. · Class I
- Tinto c-Myc (RBT-CMYC) — BIO SB, INC. · Class I
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 (8)
- FDA UDI 85d669c4-a5d3-4e92-94ed-0fac137fc872 33 fields · synced Sep 17, 2026
- FDA UDI ecc0756c-f3e3-4dcd-a57c-2c1d4eec6f14 33 fields · synced May 30, 2026
- FDA UDI ff62678b-1812-40ba-9c31-75f5e1c7a972 33 fields · synced May 30, 2026
- FDA UDI d67db349-35b1-4e05-bb9f-dbe3a5790e7c 33 fields · synced May 30, 2026
- EUDAMED 94a4ca49-1444-4bbe-b517-4110fc34479b 61 fields · synced Jul 9, 2026
- EUDAMED c69bb6b0-89dd-49d2-b133-318317e784f8 61 fields · synced Jul 17, 2026
- EUDAMED f37f9f5a-d1b0-45a6-90b8-99bb44cc9d59 61 fields · synced Aug 3, 2026
- EUDAMED da28bbce-d935-446a-894c-50e2c2c8e9f2 61 fields · synced Sep 17, 2026