Gonochek®-II Reagent Tubes

Basic Information

• Brand Name: Gonochek®-II Reagent Tubes
• Primary DI: 00863251000218
• Version / Model: 13-003-25
• Company Name: E-Y Laboratories, Inc.
• Labeler DUNS: 087212858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: ef32c727-5faa-440d-8ad8-ee54ac65ac42

Device Description

Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosidase from colonies grown on selective media, to aid in the presumptive identification of Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Moraxella (Branhamella) catarrhalis. Gonochek®-II consists of a reagent tube which contains three chromogenic substrates for use in the detection of three preformed enzymes, prolyliminopeptidase, gamma-glutamyl-aminopeptidase, and beta-galactosidase. These three enzymes have been shown to be accurate in identifying N.gonorrhoeae, N. meningitidis and N. lactamica respectively. The red cap of the Reagent Tube contains a color developer (diazo dye).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
61144	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863251000218	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 8 Degrees Celsius