Identity
- Trade Name
- BACTIDROP LACTOPHENOL EUDAMEDNA FDA UDI
- Generic Name
- Aniline blue solution IVD FDA UDI
- Device Name
- BACTIDROP LACTOPHENOL EUDAMED
- Model / Reference
- R21526 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848838023835 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380BDrpLactAniBlue83 EUDAMED
- 510(k) Number
- K913005 FDA UDI
- FDA Product Code
- JIO FDA UDI
- EMDN Code
- W0104010804 STAINS EUDAMED
- GMDN Term
- Aniline blue solution IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6550 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bactidrop Lactophenol by Remel, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8488380BDrpLactAniBlue83 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Remel, Inc.
- EUDAMED SRN
- US-MF-000044686
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 80b13210-fd6a-4b06-b6dc-9233780026ed 61 fields · synced Jul 18, 2026
- FDA UDI e05b0392-7b76-49a7-b310-485e889003a2 34 fields · synced May 30, 2026