TFE3 (MRQ-37) Rabbit Monoclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- TFE3 (MRQ-37) Rabbit Monoclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Transcription factor E3 (TFE3) IVD, antibody FDA UDI
- Device Name
- TFE3 (MRQ-37) Rabbit Monoclonal Antibody EUDAMED
- Model / Reference
- 354R-15 EUDAMEDFDA UDI354R-17 EUDAMEDFDA UDI354R-1X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683121534 EUDAMEDFDA UDI00841683121558 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831354R-1DU EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Transcription factor E3 (TFE3) 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: Transcription factor E3 (TFE3) IVD, antibody
TFE3 (MRQ-37) Rabbit 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 Transcription factor E3 (TFE3) IVD, antibody.
- Tinto TFF3 (BSB-181) — BIO SB, INC. · Class I
- Anti-TFE-3 — Biogenex Laboratories, Inc. · Class I
- Tinto TFF3 (BSB-181) — BIO SB, INC. · Class I
- TFF3 (BSB-181) — BIO SB, INC. · Class I
- TFF3 (BSB-181) — BIO SB, INC. · Class I
- Tinto TFF3 (BSB-181) — BIO SB, INC. · Class I
- TFF3 (BSB-181) — BIO SB, INC. · Class I
- TFE3 (MRQ-37) Rabbit Monoclonal Antibody — CELL MARQUE CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cell Marque Corporation
Sources (4)
- FDA UDI 713e6076-75e5-4102-954d-2b4f69fb1661 33 fields · synced Jul 21, 2026
- FDA UDI b077b5ef-7fa7-4aa0-88f8-ed632fd7a2a0 33 fields · synced May 30, 2026
- EUDAMED bfc0062d-5e59-4ba0-93f3-565dab29fd8d 61 fields · synced Jul 14, 2026
- EUDAMED 6b9a3b31-fa99-4300-99ec-bf31d9d66615 61 fields · synced Jul 21, 2026