Identity
- Trade Name
- Pointe Scientific, Inc. FDA UDI
- Generic Name
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. This assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus. 96 Tests. FDA UDI
- Model / Reference
- F1037-96 FDA UDI
- Description
- The Prolactin ELISA is intended for the quantitative determination of prolactin in human serum. This assay is useful in the diagnosis and treatment of disorders of the anterior pituitary and hypothalamus. 96 Tests. FDA UDI
Identifiers
- Catalog Number
- F1037-96 FDA UDI
- Primary DI / UDI-DI
- 00811727013279 FDA UDI
- FDA Product Code
- CFT FDA UDI
- GMDN Term
- Prolactin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1625 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Prolactin IVD, kit, enzyme immunoassay (EIA)
Pointe Scientific, Inc. by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 8c256f49-8267-4fdd-96cc-35de66c9758a 36 fields · synced May 30, 2026