Identity
- Trade Name
- Ansh Labs Glycosylated Fibronectin ELISA FDA UDI
- Generic Name
- Fibronectin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Glycosylated Fibronectin enzyme linked immunoassay (ELISA) kit provides the materials for the quantitative measurement of GlyFn in human maternal serum. This assay is intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- AL-160-i FDA UDI
- Description
- Glycosylated Fibronectin enzyme linked immunoassay (ELISA) kit provides the materials for the quantitative measurement of GlyFn in human maternal serum. This assay is intended for in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- AL-160-i FDA UDI
- Primary DI / UDI-DI
- 00853592008110 FDA UDI
- GMDN Term
- Fibronectin 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: Fibronectin IVD, kit, enzyme immunoassay (EIA)
Ansh Labs Glycosylated Fibronectin ELISA by Ansh Labs, LLC — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Ansh Labs, LLC
Sources (1)
- FDA UDI 1f57ff50-920a-4319-88e6-9026552fc85a 35 fields · synced May 30, 2026