Identity
- Trade Name
- Antibody Diluent OP Quanto EUDAMEDThermo Scientific FDA UDI
- Generic Name
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Antibody Diluent EUDAMEDAntibody Diluent OP Quanto FDA UDI
- Model / Reference
- TA-125-ADQ EUDAMEDFDA UDI
- Description
- Antibody Diluent OP Quanto FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673693560726 EUDAMEDFDA UDI
- Basic UDI-DI
- 0673693RAS058S4 EUDAMED
- Direct Marketing DI
- 00673693560726 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W01030711 IMMUNOHISTOLOGY KITS EUDAMED
- GMDN Term
- Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Netherlands 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
Dimensions & Sizes
- Size
- Total Volume — 125 Milliliter FDA UDI
Category: Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Thermo Scientific by Richard-Allan Scientific LLC — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Richard-Allan Scientific LLC
Sources (2)
- FDA UDI 2e427d47-97aa-4371-b18e-b9b152d1db74 35 fields · synced Jul 10, 2026
- EUDAMED 13d60368-9066-4489-b4a0-3d2aa8f8b952 61 fields · synced Jul 10, 2026