Identity
- Trade Name
- Aldosterone Double Antibody 125I RIA Kit FDA UDI
- Generic Name
- Aldosterone IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Radioimmunoassay for the quantitative determination of Aldosterone in human plasma or serum. FDA UDI
- Model / Reference
- 07108202 FDA UDI
- Description
- Radioimmunoassay for the quantitative determination of Aldosterone in human plasma or serum. FDA UDI
Identifiers
- Catalog Number
- 07108202 FDA UDI
- Primary DI / UDI-DI
- 00817830022269 FDA UDI
- 510(k) Number
- K862204 FDA UDI
- FDA Product Code
- CJM FDA UDI
- GMDN Term
- Aldosterone IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1045 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 — 16.5 Centimeter FDA UDI
Category: Aldosterone IVD, kit, radioimmunoassay
Aldosterone Double Antibody 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 f61770e1-e2f8-4085-977f-fb95607844da 38 fields · synced Jun 1, 2026