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SOX-11 (MRQ-58) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 382M-10Model 382M-1X seriesRef 382M-15Ref 382M-17Ref 382M-18Ref 382M-16
Identity
- Trade Name
- SOX-11 (MRQ-58) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- SOXC protein IVD, antibody FDA UDI
- Device Name
- SOX-11 (MRQ-58) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 382M-18 EUDAMEDFDA UDI382M-15 EUDAMEDFDA UDI382M-10 EUDAMEDFDA UDI382M-16 EUDAMEDFDA UDI382M-17 EUDAMEDFDA UDI382M-1X series EUDAMED382M-14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683140023 EUDAMEDFDA UDI00841683121695 EUDAMEDFDA UDI00841683105886 EUDAMEDFDA UDI00841683121701 EUDAMEDFDA UDI00841683121718 EUDAMEDFDA UDI00841683121688 FDA UDI
- Basic UDI-DI
- 008416831382M-1DN EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- SOXC 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
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: SOXC protein IVD, antibody
SOX-11 (MRQ-58) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (11)
- FDA UDI f0afba7c-9c33-4216-80e7-dedc1cf77f98 33 fields · synced Jul 19, 2026
- FDA UDI 03e402d8-e8fb-4074-9040-2619d92e54e0 33 fields · synced May 30, 2026
- FDA UDI e868b387-c22e-4c93-904c-66dae689ea1b 33 fields · synced May 30, 2026
- FDA UDI 99ae7a5a-e081-4109-8cca-dcda3595a4fc 33 fields · synced May 30, 2026
- FDA UDI 127c9fe0-df17-49aa-b913-d687d1c2b38f 33 fields · synced May 30, 2026
- FDA UDI 4908271a-2561-48db-aaae-ec6345ccf31e 33 fields · synced May 30, 2026
- EUDAMED ddb5dd4e-f026-4671-82dd-2c6aefa9e207 61 fields · synced Jun 20, 2026
- EUDAMED 7775387b-e83f-4d00-bd89-77bca6dc4eed 61 fields · synced Jul 9, 2026
- EUDAMED cdd22aae-7c3b-4abf-8cdc-f894349e28ef 61 fields · synced Jul 11, 2026
- EUDAMED 3f3e25a8-c0a8-40d3-9a3c-dabfbbfebf13 61 fields · synced Jul 12, 2026
- EUDAMED b79b76f1-955a-4609-a944-e24a0aeb4113 61 fields · synced Jul 19, 2026