Alethia™ HSV 1&2 External Control Kit 479960

GUDID 00840733102158

The Alethia™ HSV 1&2 External Control Kit contains Positive and Negative Control Reagents for use with the illumigene HSV 1&2 DNA Amplification Assay. External controls are used as part of a routine quality control program.

MERIDIAN BIOSCIENCE, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control

• Primary Device ID: 00840733102158
• NIH Device Record Key: 8ea1134d-a143-4540-8793-8e752ddf7649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alethia™ HSV 1&2 External Control Kit
• Version Model Number: 479960
• Catalog Number: 479960
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733102158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151046

FDA Product Code

• PGI: Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-09

Devices Manufactured by MERIDIAN BIOSCIENCE, INC.

• 00840733103025 - Para-Pak Modified (Cu) PVA: 2023-10-25 Para-Pak based systems provide standardized procedures for the routine collection, transportation, preservation, and examination
• 00840733101472 - Premier HpSA Flex: 2023-09-05 The Premier HpSA Flex enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori ant
• 00840733101410 - Meridian Viral Transport: 2023-08-15 Meridian Viral Transport is a system which contains all materials necessary to collect and transport clinical specimens for vira
• 00840733103308 - Curian Shiga Toxin: 2023-06-05 The Curian Shiga Toxin assay, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the simulta
• 00840733102387 - Curian Campy: 2023-03-31 Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campyloba
• 00840733103285 - Revogene Check: 2022-07-05 The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm th
• 00840733102844 - Para-Pak SAF: 2022-04-01 The Para-Pak SAF is a convenient system for the routine collection, transportation, preservation, and examination of stool speci
• 00840733101434 - BreathTek UBT for H. pylori: 2022-02-21 The BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated wi