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Previ® Color Gram Ra3 Acetone Fuchsin Solution
EUDAMEDFDA UDIClass A (EU MDR)
Ref 29521Ref 29584
Identity
- Trade Name
- PREVI® COLOR GRAM RA3 ACETONE FUCHSIN SOLUTION EUDAMEDFDA UDI
- Generic Name
- Gram stain IVD, reagent FDA UDI
- Device Name
- PREVI® COLOR GRAM RA3 ACETONE FUCHSIN SOLUTION EUDAMEDGram's method reagent used exclusively on PREVI Color Gram instrument Americas FDA UDI
- Model / Reference
- 29521 EUDAMED29584 EUDAMEDFDA UDI
- Description
- Gram's method reagent used exclusively on PREVI Color Gram instrument Americas FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026219802 EUDAMED03573026263126 EUDAMEDFDA UDI
- Basic UDI-DI
- 357302BUDI000228TA EUDAMED
- FDA Product Code
- JTS FDA UDI
- EMDN Code
- W0104010804 STAINS EUDAMED
- GMDN Term
- Gram stain IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Previ® Color Gram Ra3 Acetone Fuchsin Solution by Biomerieux Sa — 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 | 357302BUDI000228TA | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- bioMérieux SA
- EUDAMED SRN
- FR-MF-000004436
Sources (4)
- EUDAMED 8ba3f692-af68-4ce1-99b8-7a7090678c78 61 fields · synced Jul 23, 2026
- FDA UDI 9c5f11cd-fd00-474c-92c7-1eeae85564e8 34 fields · synced May 30, 2026
- EUDAMED 5517346f-e0f6-4da8-984c-e050381d6f90 61 fields · synced Jul 15, 2026
- EUDAMED bea30e81-5f34-442f-9331-3fa919752c02 61 fields · synced Jul 23, 2026