TLE1 (1F5) Mouse Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- TLE1 (1F5) Mouse Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Transducin-like enhancer protein IVD, antibody FDA UDI
- Device Name
- TLE1 (1F5) Mouse Monoclonal Antibody EUDAMED
- Model / Reference
- 401M-15 EUDAMEDFDA UDI401M-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683141129 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831401M-1B4 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Transducin-like enhancer 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: Transducin-like enhancer protein IVD, antibody
TLE1 (1F5) Mouse Monoclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Transducin-like enhancer protein IVD, antibody.
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- ANTI-TLE-1 — Biogenex Laboratories, Inc. · Class I
- ANTI-TLE 1 — Biogenex Laboratories, Inc. · Class I
- TLE 1 [EPR9386(2)] — BIOCARE MEDICAL, LLC · Class I
- TLE 1 [EPR9386(2)] — BIOCARE MEDICAL, LLC · 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 (2)
- FDA UDI 5a90c7b4-d91b-41bd-9668-33984b3a1947 33 fields · synced Jul 21, 2026
- EUDAMED 61dce943-3a09-44ce-b596-02a19b60e0db 61 fields · synced Jul 21, 2026