TTF-1 (8G7G3/1) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- TTF-1 (8G7G3/1) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Thyroid transcription factor-1 (TTF1) IVD, antibody FDA UDI
- Device Name
- TTF-1 (8G7G3/1) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 343M-97 EUDAMEDFDA UDI343M-90 EUDAMEDFDA UDI343M-95 EUDAMEDFDA UDI343M-96 EUDAMEDFDA UDI343M-94 EUDAMEDFDA UDI343M-98 EUDAMEDFDA UDI343M-9X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683137337 EUDAMEDFDA UDI00841683137290 EUDAMEDFDA UDI00841683137313 EUDAMEDFDA UDI00841683137320 EUDAMEDFDA UDI00841683137306 EUDAMEDFDA UDI00841683137344 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831343M-9CZ EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Thyroid transcription factor-1 (TTF1) 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: Thyroid transcription factor-1 (TTF1) IVD, antibody
TTF-1 (8G7G3/1) 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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Also classified as Thyroid transcription factor-1 (TTF1) 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 (12)
- FDA UDI 894202f8-ec6f-4748-9cc3-80dbe0c3dd43 33 fields · synced Jul 28, 2026
- FDA UDI bb4046b6-f82f-4c60-a00a-a4d5a3ebc489 33 fields · synced May 30, 2026
- FDA UDI 8b784227-0bc7-45f7-ae60-c2c8144de5df 33 fields · synced May 30, 2026
- FDA UDI 92ab129a-8994-4fd4-9a5a-4e397ad9ac07 33 fields · synced May 30, 2026
- FDA UDI c3dc4199-0ffd-4369-8736-cb3650ced10a 33 fields · synced May 30, 2026
- FDA UDI 0f8866c7-b698-4a72-8c61-2c1007cce198 33 fields · synced May 30, 2026
- EUDAMED 86c9c21b-cae3-46dd-9633-4c68ae31b169 61 fields · synced Jul 8, 2026
- EUDAMED 057958ed-4952-4d9d-b4c2-ca83b8f29868 61 fields · synced Jul 17, 2026
- EUDAMED d3bfb25f-a52f-4bf8-9aa6-bf579c299d49 61 fields · synced Jul 18, 2026
- EUDAMED 5aca0378-1e8f-40d0-8ce8-8ecb1a4a7788 61 fields · synced Jul 18, 2026
- EUDAMED 18b74829-19e8-44b9-aab2-e3bb0b89fbc0 61 fields · synced Jul 26, 2026
- EUDAMED b56e99b6-66ef-4ea0-9acb-07f1ab109b59 61 fields · synced Jul 28, 2026