Identity
- Trade Name
- TLiIQ System FDA UDI
- Generic Name
- Fibronectin IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- System that detects fFN in cervicovaginal secretions. FDA UDI
- Model / Reference
- TLiIQ System FDA UDI
- Description
- System that detects fFN in cervicovaginal secretions. FDA UDI
Identifiers
- Catalog Number
- 01202 FDA UDI
- Primary DI / UDI-DI
- 25420045500874 FDA UDI
- PMA Number
- P920048 FDA UDI
- FDA Product Code
- LKV FDA UDI
- GMDN Term
- Fibronectin IVD, kit, enzyme immunohistochemistry FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fibronectin IVD, kit, enzyme immunohistochemistry
TLiIQ System by Hologic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibronectin IVD, kit, enzyme immunohistochemistry.
- TLiIQ System — Hologic, Inc. · Class III
- TLiIQ System — Hologic, Inc. · Class III
- Rapid fFN® — Hologic, Inc. · Class III
- Rapid fFN® — Hologic, Inc. · Class III
- TLI IQ® — Hologic, Inc. · Class III
Cleared under the same submission
P920048 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI 6020f1f8-fc11-433d-8785-fce615105dc2 37 fields · synced May 30, 2026