STAT6 (EP325) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- STAT6 (EP325) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- Signal transducer and activator of transcription (STAT) protein IVD, antibody FDA UDI
- Device Name
- STAT6 (EP325) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 426R-17 EUDAMEDFDA UDI426R-14 EUDAMEDFDA UDI426R-15 EUDAMEDFDA UDI426R-16 EUDAMEDFDA UDI426R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683106203 EUDAMEDFDA UDI00841683106197 EUDAMEDFDA UDI00841683106180 EUDAMEDFDA UDI00841683106210 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831426R-1DN EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Signal transducer and activator of transcription (STAT) 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: Signal transducer and activator of transcription (STAT) protein IVD, antibody
STAT6 (EP325) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Signal transducer and activator of transcription (STAT) protein IVD, antibody.
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- Tinto STAT6 (RM473) — BIO SB, INC. · Class I
- Rabbit Monoclonal Anti-Human STAT6, EP325 — EPITOMICS, 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 ade4e56d-4b8f-4eb4-9bd4-e29f592f815b 33 fields · synced Aug 1, 2026
- FDA UDI d560797f-dfc9-4d92-9e59-aedb2ec6ce55 33 fields · synced May 30, 2026
- FDA UDI 2e132929-1ceb-4b2b-886e-d03edef6f360 33 fields · synced May 30, 2026
- FDA UDI dbc93b52-2b7d-4bc6-ba0c-aa429b3c1ad7 33 fields · synced May 30, 2026
- EUDAMED 674c1200-0dfa-49c0-a495-97fbe93ea99b 61 fields · synced Jul 11, 2026
- EUDAMED 8ad04cd0-f827-46dc-90d3-b1af409e622b 61 fields · synced Jul 20, 2026
- EUDAMED 5cf9f6bf-7db1-45c0-957d-cae41f38558f 61 fields · synced Jul 20, 2026
- EUDAMED abbcee0a-7733-4dfd-ad83-debae1265421 61 fields · synced Aug 1, 2026