Identity
- Trade Name
- GRAM STAIN KIT EUDAMEDREMEL FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- GRAM STAIN KIT EUDAMEDGram Stain Set 4 x 250mL w/ Tray FDA UDI
- Model / Reference
- R40080 EUDAMEDFDA UDI
- Description
- Gram Stain Set 4 x 250mL w/ Tray FDA UDI
Identifiers
- Catalog Number
- R40080 FDA UDI
- Primary DI / UDI-DI
- 00848838065699 EUDAMEDFDA UDI
- Basic UDI-DI
- 8488380GramStainSet22 EUDAMED
- FDA Product Code
- JTS FDA UDI
- EMDN Code
- W0104010804 STAINS EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 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
Gram Stain Kit 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 | 8488380GramStainSet22 | 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 d8514e0b-b04f-4a71-a83b-8ecfa5964cb9 61 fields · synced Jun 18, 2026
- FDA UDI f480cec8-005a-467b-bec5-61204268548a 34 fields · synced May 30, 2026