Gonochek®-II Reagent Tubes

GUDID 00863251000218

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).

E-Y Laboratories, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical

• Primary Device ID: 00863251000218
• NIH Device Record Key: ef32c727-5faa-440d-8ad8-ee54ac65ac42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gonochek®-II Reagent Tubes
• Version Model Number: 13-003-25
• Company DUNS: 087212858
• Company Name: E-Y Laboratories, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com
• Phone: 6503423296
• Email: orders@eylabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863251000218 [Primary]

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: 2023-09-11
• Device Publish Date: 2023-09-01

Devices Manufactured by E-Y Laboratories, Inc.

• 00863251000201 - Strep-A-Chek(TM) Kit: 2023-09-11 Strep-A-Chekâ„¢ Kit is intended for use in the detection of pyrrolidonyl arylamidase (PYR) from beta-hemolytic colonies grown on
• 00863251000218 - Gonochek®-II Reagent Tubes: 2023-09-11Gonochek®-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).
• 00863251000218 - Gonochek®-II Reagent Tubes: 2023-09-11 Gonochek®-II is intended for the use in the detection of prolyliminopeptidase, gammaglutamylaminopeptidase, and beta-galactosid
• 00863251000225 - Strep-A-Chek(TM) Strips (100 pcs): 2023-09-11 Strep-A-Chekâ„¢ Reagent Strips are paper strips impregnated with a chromogenic substrate for the detection of pyrrolidonyl aryla
• 00863251000232 - EY-20(TM) Reagent Tube: 2023-09-11 The EY-20â„¢ Reagent Tubes are a component of the Strep-A-Chekâ„¢ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chekâ