Identity
- Trade Name
- PREVI® Color Gram RA4 FUCHSIN solution FDA UDI
- Generic Name
- Gram stain IVD, reagent FDA UDI
- Device Name
- Gram's method reagent used exclusively on PREVI Color Gram instrument North America FDA UDI
- Model / Reference
- 29585 FDA UDI
- Description
- Gram's method reagent used exclusively on PREVI Color Gram instrument North America FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026263133 FDA UDI
- FDA Product Code
- JTS FDA UDI
- GMDN Term
- Gram stain IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Category: Gram stain IVD, reagent
PREVI® Color Gram RA4 FUCHSIN solution by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Gram stain IVD, reagent.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
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
- Biomerieux , Inc.
Sources (2)
- FDA UDI 539a065a-ef5c-4b87-a0d5-fb48ffe4fb47 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 14, 2026