LEF1 (EP310) Rabbit Monoclonal Primary Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- LEF1 (EP310) Rabbit Monoclonal Primary Antibody EUDAMEDFDA UDI
- Generic Name
- Lymphoid enhancer factor 1 (LEF1) IVD, antibody FDA UDI
- Device Name
- LEF1 (EP310) Rabbit Monoclonal Primary Antibody EUDAMED
- Model / Reference
- 442R-14 EUDAMEDFDA UDI442R-16 EUDAMEDFDA UDI442R-18 EUDAMEDFDA UDI442R-1X series EUDAMED442R-15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841683106258 EUDAMEDFDA UDI00841683105008 EUDAMEDFDA UDI00841683104995 EUDAMEDFDA UDI00841683124726 FDA UDI
- Basic UDI-DI
- 008416831442R-1DG EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Lymphoid enhancer factor 1 (LEF1) 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: Lymphoid enhancer factor 1 (LEF1) IVD, antibody
LEF1 (EP310) Rabbit Monoclonal Primary Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Lymphoid enhancer factor 1 (LEF1) IVD, antibody.
- Rabbit Monoclonal Anti-Human LEF-1 Antibody, EP310 — EPITOMICS, INC. · Class I
- LEF1 (RBT-LEF1) — BIO SB, INC. · Class I
- BOND — Leica Biosystems Newcastle, Limited · Class I
- LEF1 (RBT-LEF1) — BIO SB, INC. · Class I
- Rabbit Monoclonal Anti-Human LEF-1 Antibody, EP310 — EPITOMICS, INC. · Class I
- Rabbit Monoclonal Anti-Human LEF-1 Antibody, EP310 — EPITOMICS, INC. · Class I
- Tinto LEF1 (RBT-LEF1) — BIO SB, INC. · Class I
- Rabbit Monoclonal Anti-Human LEF-1 Antibody, EP310 — 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 (7)
- FDA UDI be3fd782-931c-44fd-8fd2-eeffbda11980 33 fields · synced Aug 3, 2026
- FDA UDI bf6e30ca-4b4a-40c7-aadd-5a697b084334 33 fields · synced May 30, 2026
- FDA UDI 8e0b8e35-0212-4ff0-88e9-439426716d01 33 fields · synced May 30, 2026
- FDA UDI 27f55eac-138f-4409-ac1f-e04be2231fba 33 fields · synced May 30, 2026
- EUDAMED ebcbf95e-6976-4f8a-8f31-ff16f6ce90de 61 fields · synced Jul 17, 2026
- EUDAMED 0b4acacc-ccca-4f13-9e03-b6ffaf469474 61 fields · synced Jul 18, 2026
- EUDAMED a6dae1c1-6a9f-4f9d-99b8-00cefb8c9092 61 fields · synced Aug 3, 2026