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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 is for use on the Panther® System. FDA UDI
Model / Reference
KIT, AUTO DETECT, APTIMA, AS FDA UDI
Description
The Aptima® Auto Detect Kit is for use on the Panther® System. FDA UDI

Identifiers

Catalog Number
303013 FDA UDI
Primary DI / UDI-DI
15420045500273 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI 91e02618-fc15-4262-a2cd-46eeb8c742e6 36 fields · synced May 30, 2026