MyoD1 (EP212) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- MyoD1 (EP212) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- Myo-D1 protein rhabdomyosarcoma marker IVD, antibody FDA UDI
- Device Name
- MyoD1 (EP212) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 760-4900 EUDAMEDFDA UDI386R-14 EUDAMEDFDA UDI386R-15 EUDAMEDFDA UDI386R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683101574 EUDAMEDFDA UDI00841683121763 EUDAMEDFDA UDI00841683121770 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831760-49002K EUDAMED008416831386R-1FB EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Myo-D1 protein rhabdomyosarcoma marker 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
Yes
Category: Myo-D1 protein rhabdomyosarcoma marker IVD, antibody
MyoD1 (EP212) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Myo-D1 protein rhabdomyosarcoma marker 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 a552a44a-1ca2-46d4-9152-7c498906825d 33 fields · synced Jul 25, 2026
- FDA UDI a0741baa-c8d0-47f9-be70-c19960d91496 33 fields · synced May 30, 2026
- FDA UDI 332cd839-07d7-4d59-ad79-603cd553cdda 33 fields · synced May 30, 2026
- EUDAMED 2a443845-5159-4726-ae98-86a96573a240 61 fields · synced Jul 9, 2026
- EUDAMED 59a4f51d-9f6b-4a5f-9c98-9c9606921bad 61 fields · synced Jul 10, 2026
- EUDAMED 77aa6cba-87b3-486d-b9c5-2fede3dce8f2 61 fields · synced Jul 25, 2026