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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Aptima® FDA UDI
Generic Name
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD FDA UDI
Device Name
The Aptima® Auto Detect Kit. This kit is to be used with the Leader® HC+ Luminometer and the Tigris® instrument system. FDA UDI
Model / Reference
APTIMA AUTO DETECT KIT (CE) FDA UDI
Description
The Aptima® Auto Detect Kit. This kit is to be used with the Leader® HC+ Luminometer and the Tigris® instrument system. FDA UDI

Identifiers

Catalog Number
301048 FDA UDI
Primary DI / UDI-DI
15420045500259 FDA UDI
510(k) Number
K060652 FDA UDI
FDA Product Code
LSL FDA UDI
MKZ FDA UDI
GMDN Term
Nucleic acid technique (NAT) chemiluminescent signal generation 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

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: Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

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

Similar devices

Also classified as Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD.

Cleared under the same submission

K060652 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 7d7675e9-63cf-44b1-94ff-46e3bcbe5b88 37 fields · synced Jun 1, 2026