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Bactidrop Indole (kovacs)
EUDAMEDFDA UDIClass A (EU MDR)
Ref R21522
by Remel, Inc.
Identity
- Trade Name
- BACTIDROP INDOLE (KOVACS) EUDAMEDBACTIDROP FDA UDI
- Generic Name
- Indole/Kovac's microbial reagent IVD FDA UDI
- Device Name
- BACTIDROP INDOLE (KOVACS) EUDAMEDBactiDrop Indole,Kovacs PK/50 FDA UDI
- Model / Reference
- R21522 EUDAMEDFDA UDI
- Description
- BactiDrop Indole,Kovacs PK/50 FDA UDI
Identifiers
- Catalog Number
- R21522 FDA UDI
- Primary DI / UDI-DI
- 00848838023811 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380BDrpIndoleKovP2 EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Indole/Kovac's microbial reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Bactidrop Indole (kovacs) 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 | 8488380BDrpIndoleKovP2 | 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 ad997eb5-b9c4-4721-9fa6-24ea7279ffef 61 fields · synced Jul 24, 2026
- FDA UDI 3d971819-dbc0-47fd-94b9-f230bd875587 34 fields · synced May 30, 2026