- Physicians Office Resource

Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Aptima® - KIT, APTIMA HPV 16 18/45, 100 REF IVD

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen, using a nucleic acid technique (NAT).

Environmental Conditions

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OYB

Device Name: Kit, Rna Detection, Human Papillomavirus

Device Class: 3

Physical State: Device is supplied as an in vitro diagnositc kit containing various reagents, instructions for use and possibly instrumentation and software.

Definition: For the detection of human papillomavirus RNA to aid in assessing risk of cancer.

Submission Type ID: 2

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Utilizes nucleic acid probes and/or primers along with other reagents to detect human papillomavirus RNA directly from human specimens

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Currently, this type of device is only utilized on cervical specimens, but other specimen types are possible.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 15420045500112

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.