Identity
- Trade Name
- Gonochek®-II Reagent Tubes FDA UDI
- Generic Name
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- 13-003-25 FDA UDI
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863251000218 FDA UDI
- GMDN Term
- Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Gonochek®-II Reagent Tubes by E-Y Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical.
- Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack — Visby Medical, Inc. · Class II
- Male Urethral Collection Kit for BD ProbeTec™ (CT/GC) Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- cobas® PCR Urine Sample Kit — Roche Molecular Systems, Inc. · Class II
- Aptima® — Hologic, Inc. · Class I
- BD Vaginal Specimen Transport for the BD ProbeTec™ Qx Amplified DNA Assays — BECTON DICKINSON AND COMPANY · Class II
- Visby Medical Power Adapter — Visby Medical, Inc. · Class II
- binx io — Binx Health, Inc. · Class I
- BD Molecular Swab Collection Kit — BECTON DICKINSON AND COMPANY · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- E-Y Laboratories, Inc.
Sources (1)
- FDA UDI ef32c727-5faa-440d-8ad8-ee54ac65ac42 35 fields · synced Jun 1, 2026