Aptima Hpv 16 18/45 Genotype Assay

EUDAMED lists no certificate for this device's Basic UDI-DI.

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No FDA recalls found in the data synced 12 Oct 2026.

Trade Name

Aptima Hpv 16 18/45 Genotype Assay EUDAMEDPMA

Aptima® GUDID

Generic Name

Kit, rna detection, human papillomavirus PMA

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) GUDID

Model / Ref / Catalog

303236 EUDAMED

KIT GUDID

APTIMA HPV 16 18/45 GUDID

100 RT IVD GUDID

303231 GUDID

Primary DI / UDI-DI

15420045500129

Basic UDI-DI

54200455DIAGAPTHPVGTVK

Direct Marketing DI

15420045500129

PMA Number

P120007 ↗

FDA Product Code

OYB

EMDN Code

W0105041003 Partial genotyping high-risk hpv - na reagents

GMDN Term

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)

Device Class

Class C EUDAMED

Class III PMAGUDID

EU market of registration

Belgium

Advisory Committee

Microbiology

FDA Decision

APPR Approved

GUDID distribution status

In Commercial Distribution

• Aptima Trichomonas Vaginalis Assay

  Class II

  FDA De Novo DEN110012 Active Cleared 19 Apr 2011 FDA 510(k)

• Progensa PCA3 Assay

  Class III

  FDA PMA P100033 Withdrawn Approved 13 Feb 2012

• Aptima HPV Assay Open recall

  Class III

  FDA PMA P100042 Active Approved 28 Oct 2011

• What is the Aptima Hpv 16 18/45 Genotype Assay used for?

  The Aptima Hpv 16 18/45 Genotype Assay is used to detect Hpv types 16, 18, and 45 in cervical specimens from women with Aptima Hpv Assay positive results. It is indicated for use in patients 21 years and older with atypical squamous cells of undetermined significance (Asc-Us) cervical cytology results, and in women 30 years and older.

• How does the Aptima Hpv 16 18/45 Genotype Assay work?

  The Aptima Hpv 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test that uses the Tigris Dts system to detect E6/E7 viral messenger RNA (mRNA) of human papillomavirus (Hpv) types 16, 18, and 45 in cervical specimens.

• What are the limitations of the Aptima Hpv 16 18/45 Genotype Assay?

  The Aptima Hpv 16 18/45 Genotype Assay does not differentiate between Hpv 18 and Hpv 45, and the results are not intended to prevent women from proceeding to colposcopy. The assay results should be used in combination with cervical cytology and the physician's assessment of cytology history, other risk factors, and professional guidelines to guide patient management.