Identity
- Trade Name
- Conjugated Bile Acids 125I RIA Kit FDA UDI
- Generic Name
- Conjugated sulfalithocholic acid (SLCG) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Radioimmunoassay for the quantitative determination of conjugated bile acids in human serum or plasma. FDA UDI
- Model / Reference
- 06B242918 FDA UDI
- Description
- Radioimmunoassay for the quantitative determination of conjugated bile acids in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- 06B242918 FDA UDI
- Primary DI / UDI-DI
- 00817830022290 FDA UDI
- 510(k) Number
- K781337 FDA UDI
- FDA Product Code
- KWW FDA UDI
- GMDN Term
- Conjugated sulfalithocholic acid (SLCG) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1177 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 28 Centimeter FDA UDI
Category: Conjugated sulfalithocholic acid (SLCG) IVD, kit, radioimmunoassay
Conjugated Bile Acids 125I RIA Kit by Mp Biomedicals, Llc — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Mp Biomedicals, Llc
Sources (1)
- FDA UDI 865855f9-c6af-43c6-9806-ca5fc22ee5ce 38 fields · synced Jun 8, 2026