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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Aptima® FDA UDI
Generic Name
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
Aptima® Mycoplasma genitalium Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI
Model / Reference
KIT, BX 2 (RT) M GEN, 100T, AS, IVD FDA UDI
Description
Aptima® Mycoplasma genitalium Assay, 100 test, box 2 of 2 (15°C to 30°C box). FDA UDI

Identifiers

Catalog Number
ASY-09408 FDA UDI
Primary DI / UDI-DI
15420045509153 FDA UDI
FDA Product Code
QEP FDA UDI
GMDN Term
Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3393 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: Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT)

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

Similar devices

Also classified as Mycoplasma genitalium nucleic acid IVD, kit, nucleic acid technique (NAT).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hologic, Inc.

Sources (1)

  • FDA UDI ced65bd2-8d4a-4506-b624-2291c2f65eee 36 fields · synced Jun 1, 2026