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.
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| 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 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| orders@eylabs.com | |
| Phone | 6503423296 |
| 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-Chek™ 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-Chek™ 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-20™ Reagent Tubes are a component of the Strep-A-Chek™ kit (Cat. No: 13-050-00) and are to be used with Strep-A-Chek� |
Trademark Results [Gonochek]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GONOCHEK 73472306 1338624 Dead/Cancelled |
E-Y Laboratories, Inc. 1984-03-26 |
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