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TLiIQ System

FDA UDI

Class III (US FDA UDI)

by Hologic, Inc.

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 Analyzer FDA UDI
Description
System that detects fFN in cervicovaginal secretions. FDA UDI

Identifiers

Catalog Number
71580-001 FDA UDI
Primary DI / UDI-DI
15420045500884 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

No

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.

Cleared under the same submission

P920048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 9266706a-f812-4ad2-8e82-d159a4b3551c 37 fields · synced May 31, 2026