Identity
- Trade Name
- Rowley Biochemical Gelatin FDA UDI
- Generic Name
- Mucopolysaccharide fraction IVD, kit, liquid chromatography FDA UDI
- Device Name
- Gelatin FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Gelatin FDA UDI
Identifiers
- Catalog Number
- E-5 FDA UDI
- Primary DI / UDI-DI
- E5852042008 FDA UDI
- FDA Product Code
- IEX FDA UDI
- GMDN Term
- Mucopolysaccharide fraction IVD, kit, liquid chromatography 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
Category: Mucopolysaccharide fraction IVD, kit, liquid chromatography
Rowley Biochemical Gelatin by Transene Company, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Transene Company, Inc.
Sources (1)
- FDA UDI d50fb702-7704-42fc-9f52-02bda3f558ef 34 fields · synced Jun 8, 2026