Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name: Aptima® FDA UDI
Generic Name: Nucleic acid technique (NAT) kit IVD FDA UDI
Device Name: The Aptima® System Fluid Preservative Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the System Fluid Preservative Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual. FDA UDI
Model / Reference: KIT, AC2 SYS FL PRES,TIG,IVD-CE (302380) FDA UDI
Description: The Aptima® System Fluid Preservative Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the System Fluid Preservative Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual. FDA UDI

Identifiers

Catalog Number: 302380 FDA UDI
Primary DI / UDI-DI: 15420045500266 FDA UDI
510(k) Number: K060652 FDA UDI
FDA Product Code: LSL FDA UDI
MKZ FDA UDI
GMDN Term: Nucleic acid technique (NAT) kit IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 866.3390 FDA UDI
866.3120 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

FDA UDI

Manufacturing Date

FDA UDI

Category: Nucleic acid technique (NAT) kit IVD

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

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Cleared under the same submission

K060652 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 c8a45a20-410b-43a1-804e-fd2f4d7dbb10 37 fields · synced May 30, 2026