Identity
- Trade Name
- Rowley Biochemical Bouin's Fluid FDA UDI
- Generic Name
- Bouin's solution IVD FDA UDI
- Device Name
- Bouin's Fluid FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Bouin's Fluid FDA UDI
Identifiers
- Catalog Number
- SO-306 FDA UDI
- Primary DI / UDI-DI
- SO306852042008 FDA UDI
- FDA Product Code
- IGN FDA UDI
- GMDN Term
- Bouin's solution IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 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
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 1 Gallon FDA UDITotal Volume — 1 Quart FDA UDITotal Volume — 1 Pint FDA UDITotal Volume — 8 Fluid Ounce FDA UDITotal Volume — 4 Fluid Ounce FDA UDI
Category: Bouin's solution IVD
Rowley Biochemical Bouin's Fluid by Transene Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bouin's solution IVD.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Transene Company, Inc.
Sources (1)
- FDA UDI 1e99e50d-738a-4c0e-81c3-32bb53cef818 35 fields · synced Jun 1, 2026