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PREVI® Color Gram RB IODINE solution
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 29586Ref 29523
Identity
- Trade Name
- PREVI® Color Gram RB IODINE solution EUDAMEDFDA UDI
- Generic Name
- Gram stain IVD, reagent FDA UDI
- Device Name
- PREVI® COLOR GRAM RB IODINE SOLUTION EUDAMEDGram's method reagent used exclusively on PREVI Color Gram instrument North America FDA UDI
- Model / Reference
- 29586 EUDAMEDFDA UDI29523 EUDAMED
- Description
- Gram's method reagent used exclusively on PREVI Color Gram instrument North America FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026263140 EUDAMEDFDA UDI03573026219826 EUDAMED
- Basic UDI-DI
- 357302BUDI000230SV 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
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 RB IODINE solution by Biomerieux , Inc. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gram stain IVD, reagent.
- LanaGram™ — HARDY DIAGNOSTICS · Class I
- BD BBL™ Gram Stain Kit — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Gram Safranin — BECTON DICKINSON AND COMPANY · Class I
- BD BBL™ Dobell and O’Connor Iodine Stain Droppers — BECTON DICKINSON AND COMPANY · Class I
- Crystal Violet — PRO-LAB, INCORPORATED · Class I
- PREVI® Color Gram RC CRYSTAL VIOLET solution — BIOMERIEUX , INC. · Class I
- PREVI® Color Gram RA2 SAFRANIN solution — BIOMERIEUX , INC. · Class I
- PREVI® Color Gram RA4 FUCHSIN solution — BIOMERIEUX , INC. · Class I
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 (3)
- FDA UDI 62ef735e-1c44-4bb5-82d7-a0317cbf2676 34 fields · synced Jul 10, 2026
- EUDAMED cef082ec-ff43-44bb-98e6-c253a42c6871 61 fields · synced Jul 9, 2026
- EUDAMED 129f0688-ac09-4b65-ba03-9ebdf3dfdfe3 61 fields · synced Jul 10, 2026