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Rapid fFN®

FDA UDI

Class III (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Rapid fFN® FDA UDI
Generic Name
Fibronectin IVD, kit, enzyme immunohistochemistry FDA UDI
Device Name
Rapid fFN® Control Kit (Rapid fFN® for the TLI IQ® System). FDA UDI
Model / Reference
KIT, RAPID FFN CONTROL TLIIQ SYSTEM, USA FDA UDI
Description
Rapid fFN® Control Kit (Rapid fFN® for the TLI IQ® System). FDA UDI

Identifiers

Catalog Number
01166 FDA UDI
Primary DI / UDI-DI
15420045501164 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fibronectin IVD, kit, enzyme immunohistochemistry

Rapid fFN® 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 6fb30871-ccc6-42ad-937b-ade46eae4d88 37 fields · synced May 30, 2026