Identity
- Trade Name
- NATtrol™ FDA UDI
- Generic Name
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control FDA UDI
- Device Name
- NATtrol™ GI Controls (NATGIC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus Type 41, C. difficile, C. parvum, E. coli (92.0147; EAEC1), E. coli (EDL933; O157), P. shigelloides, Rotavirus,S. sonnei, Sapovirus ( S. cerevisiae recombinant), V. cholera non-toxigenic, Y. enterocolitica, Astrovirus (S. cerevisiae recombinant),C. cayetanensis (S. cerevisiae recombinant), C. coli, C. jejuni, E. coli (7.1493; O84:H28; EPEC1),E. coli (ETEC; ST+, LT+), E. histolytica,G. lamblia,Norovirus GI (recombinant), Norovirus GII (recombinant),S. enterica typhimurium. FDA UDI
- Model / Reference
- NATtrol™ GI Controls FDA UDI
- Description
- NATtrol™ GI Controls (NATGIC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus Type 41, C. difficile, C. parvum, E. coli (92.0147; EAEC1), E. coli (EDL933; O157), P. shigelloides, Rotavirus,S. sonnei, Sapovirus ( S. cerevisiae recombinant), V. cholera non-toxigenic, Y. enterocolitica, Astrovirus (S. cerevisiae recombinant),C. cayetanensis (S. cerevisiae recombinant), C. coli, C. jejuni, E. coli (7.1493; O84:H28; EPEC1),E. coli (ETEC; ST+, LT+), E. histolytica,G. lamblia,Norovirus GI (recombinant), Norovirus GII (recombinant),S. enterica typhimurium. FDA UDI
Identifiers
- Catalog Number
- NATGIC-BIO-IVD FDA UDI
- Primary DI / UDI-DI
- 01220000260481 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-type gastrointestinal 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 gastrointestinal pathogen nucleic acid IVD, control
NATtrol™ by ZeptoMetrix LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple-type gastrointestinal pathogen nucleic acid IVD, control.
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- EasyScreen™ Gastrointestinal Parasite PCR Positive Control — Genetic Signatures Limited · Class II
- Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · Class II
- Helix Elite Molecular Standards — MICROBIOLOGICS, INC. · Class I
- Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS, INC. · Class I
- QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS, INC. · 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ZeptoMetrix LLC
Sources (1)
- FDA UDI 35111b40-2029-41ff-8f6f-03f7041762ba 36 fields · synced Jun 8, 2026