TdT Rabbit Polyclonal Antibody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- TdT Rabbit Polyclonal Antibody EUDAMEDFDA UDI
- Generic Name
- Terminal deoxynucleotidyl transferase (TdT) IVD, antibody FDA UDI
- Device Name
- TdT Rabbit Polyclonal Antibody EUDAMED
- Model / Reference
- 338A-75 EUDAMEDFDA UDI338A-77 EUDAMEDFDA UDI338A-76 EUDAMEDFDA UDI338A-7X series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841683136996 EUDAMEDFDA UDI00841683137016 EUDAMEDFDA UDI00841683137009 EUDAMEDFDA UDI
- Basic UDI-DI
- 008416831338A-7BR EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
- GMDN Term
- Terminal deoxynucleotidyl transferase (TdT) 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: Terminal deoxynucleotidyl transferase (TdT) IVD, antibody
TdT Rabbit Polyclonal Antibody by Cell Marque Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Terminal deoxynucleotidyl transferase (TdT) IVD, antibody.
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- Mono Mo A-Hu Terminal Deoxynucleotidyl Transferase/FITC Cl HT-6 — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · 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 (6)
- FDA UDI 1475812b-a1e3-4cd9-a072-4639c926f12e 33 fields · synced Jul 21, 2026
- FDA UDI 8025cdb0-b00d-4f8c-8073-c46c99ffa154 33 fields · synced May 30, 2026
- FDA UDI 8aa2b16b-e5e9-4228-8583-53f71451c966 33 fields · synced May 30, 2026
- EUDAMED 0d852e0f-0533-4640-b343-5ce22b0ac821 61 fields · synced Jul 10, 2026
- EUDAMED 50d0e5ed-0e85-4fd6-93e1-59e3bec92eb0 61 fields · synced Jul 11, 2026
- EUDAMED c85dbcd5-4121-42cb-a838-c8ae10ac68e0 61 fields · synced Jul 21, 2026