- Physicians Office Resource

Aptima® HSV 1 & 2 Assay, 100 test, box 1 of 2 (2°C to 8°C box).
Aptima® - KIT, BOX 1, REFRIG, AHSV, 100T, 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 herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) 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: OQO

Device Name: Herpes Simplex Virus Nucleic Acid Amplification Assay

Device Class: 2

Physical State: Plasma, serum, swab, culture isolates

Definition: A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Polymerase chain reaction (PCR)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (HSV) DNA

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Systemic

Regulation Number: 866.3305

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 15420045507210

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

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