Identity
- Trade Name
- NATtrol™ FDA UDI
- Generic Name
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
- Device Name
- NATtrol™ CT/NG/TV External Run Control Kit are qualitative positive and negative external run controls intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance. FDA UDI
- Model / Reference
- NATtrol CT/NG/TV External Run Control Kit FDA UDI
- Description
- NATtrol™ CT/NG/TV External Run Control Kit are qualitative positive and negative external run controls intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance. FDA UDI
Identifiers
- Catalog Number
- NATCTNGTV-ERCK-IVD FDA UDI
- Primary DI / UDI-DI
- 01220000260542 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-type sexually transmitted pathogen nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- 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
No
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
No
FDA UDI
Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, control
NATtrol™ by ZeptoMetrix LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | Class I | Pending data |
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Manufacturer
- Manufacturer
- ZeptoMetrix LLC
Sources (1)
- FDA UDI a3ec2ff0-08cf-4fe2-8ef6-157ceed07b60 36 fields · synced May 29, 2026