Identity
- Trade Name
- Ansh Labs Unconjugated Estriol EIA FDA UDI
- Generic Name
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Unconjugated Estriol Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. This assay is intended for in vitro Diagnostic Use Only. The test may help aid in the diagnosis and treatment of fetoplacental distress. FDA UDI
- Model / Reference
- AL-138 FDA UDI
- Description
- The Unconjugated Estriol Enzyme Immunoassay (EIA) Kit provides materials for the quantitative measurement of unconjugated estriol in serum. This assay is intended for in vitro Diagnostic Use Only. The test may help aid in the diagnosis and treatment of fetoplacental distress. FDA UDI
Identifiers
- Catalog Number
- AL-138 FDA UDI
- Primary DI / UDI-DI
- 00853592008271 FDA UDI
- GMDN Term
- Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- 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
No
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
Yes
FDA UDI
Category: Free estriol (oestriol) IVD, kit, enzyme immunoassay (EIA)
Ansh Labs Unconjugated Estriol EIA by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ansh Labs Unconjugated Estriol EIA — Ansh Labs, LLC
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ansh Labs, LLC
Sources (1)
- FDA UDI c8b4f1dd-6bcc-4ea3-8a0b-3b54942be76b 35 fields · synced May 30, 2026