Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Ferritin for the quantitative determination of human ferritin concentration in human serum. 96 Tests. FDA UDI
- Model / Reference
- P1025-96 FDA UDI
- Description
- Ferritin for the quantitative determination of human ferritin concentration in human serum. 96 Tests. FDA UDI
Identifiers
- Catalog Number
- P1025-96 FDA UDI
- Primary DI / UDI-DI
- 00811727013323 FDA UDI
- 510(k) Number
- K992517 FDA UDI
- FDA Product Code
- DBF FDA UDI
- GMDN Term
- Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5340 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
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
Category: Ferritin IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ferritin IVD, kit, enzyme immunoassay (EIA).
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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI c63594a4-8e67-42e2-90cd-3b27963d6893 37 fields · synced May 30, 2026