Aptima® - MULTITEST SWAB COLLECTION KIT, IVD
Device Description
A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of cellular and/or other material collected from the endocervix, vagina, and other male/female lower urogenital area (e.g., urethra) for in vitro diagnostic investigation [e.g., microbiological culture, histopathological cervical cancer screening]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium (e.g., preservative solution, Amies/Stuart transport medium); initial preparation/fixation/preservation materials may also be included in the kit. This is a single-use device.
Environmental Conditions
No Data Available
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 IdentifiersDevice Id: 25420045507248
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
Device Id: 15420045507241
Device Type: Unit of Use
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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