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Aptima®

FDA UDI

Class II (US FDA UDI)

by Hologic, Inc.

Identity

Trade Name
Aptima® FDA UDI
Generic Name
Cytomegalovirus (CMV) nucleic acid IVD, reagent FDA UDI
Device Name
Aptima® CMV Quant Assay Target Enhancer Reagent. FDA UDI
Model / Reference
CMV, TER, APTIMA, IVD FDA UDI
Description
Aptima® CMV Quant Assay Target Enhancer Reagent. FDA UDI

Identifiers

Catalog Number
PRD-05077 FDA UDI
Primary DI / UDI-DI
15420045514560 FDA UDI
PMA Number
P210029 FDA UDI
510(k) Number
K243935 FDA UDI
FDA Product Code
PAB FDA UDI
GMDN Term
Cytomegalovirus (CMV) nucleic acid IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3180 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: Cytomegalovirus (CMV) nucleic acid IVD, reagent

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

Similar devices

Also classified as Cytomegalovirus (CMV) nucleic acid IVD, reagent.

Cleared under the same submission

K243935 also covers:

P210029 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 cb52f5f4-b760-4f25-9555-55aa0e711cbf 37 fields · synced May 30, 2026