Panther Fusion®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: Panther Fusion® FDA UDI
Generic Name: Exogenous DNA/RNA internal control IVD, kit FDA UDI
Device Name: Panther Fusion® Internal Control-S. FDA UDI
Model / Reference: KIT, INTERNAL CONTROL -S, FUSION, IVD FDA UDI
Description: Panther Fusion® Internal Control-S. FDA UDI

Identifiers

Catalog Number: PRD-04332 FDA UDI
Primary DI / UDI-DI: 15420045509221 FDA UDI
510(k) Number: K171963 FDA UDI
K172282 FDA UDI
K172629 FDA UDI
K222736 FDA UDI
FDA Product Code: OEM FDA UDI
OOU FDA UDI
QOF FDA UDI
OCC FDA UDI
GMDN Term: Exogenous DNA/RNA internal control IVD, kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3980 FDA UDI
866.3981 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Exogenous DNA/RNA internal control IVD, kit

Panther Fusion® by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Exogenous DNA/RNA internal control IVD, kit.

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MGB Alert Internal Control Set IC2-48rxn — ELITechGroup MDX LLC. · Class I
MGB Alert Internal Control Set IC2-T — ELITechGroup MDX LLC. · Class I
D CTRL 1 Kit — EXACT SCIENCES CORPORATION · Class III
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MGB Alert Internal Control Set IC2-480 rxn — ELITechGroup MDX LLC. · Class I

Cleared under the same submission

K171963 also covers:

Panther Fusion® — Hologic, Inc.
Panther Fusion® — Hologic, Inc.

K172282 also covers:

Panther Fusion® — Hologic, Inc.
Panther Fusion® — Hologic, Inc.

K222736 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 II	Pending data

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Manufacturer

Manufacturer: Hologic, Inc.

Sources (1)

FDA UDI 80155078-70ef-452f-9471-48e12b605033 37 fields · synced Jun 8, 2026