Identity
- Trade Name
- NATtrol™ FDA UDI
- Generic Name
- Multiple-type meningitis-associated microorganism nucleic acid IVD, control FDA UDI
- Device Name
- NATtrol™ Meningitis/Encephalitis (ME) Controls (NATMEC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Cytomegalovirus, E. coli, Echovirus Type 11, HHV-6B, S. pneumoniae, C. gattii, HSV-1, N. meningitidis serogroup A, S. agalactiae, H. influenzae, HSV-2, L. monocytogenes serotype 1/2b, Parechovirus Type 3, VZV. FDA UDI
- Model / Reference
- NATtrol™ Meningitis/Encephalitis (ME) Controls FDA UDI
- Description
- NATtrol™ Meningitis/Encephalitis (ME) Controls (NATMEC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Cytomegalovirus, E. coli, Echovirus Type 11, HHV-6B, S. pneumoniae, C. gattii, HSV-1, N. meningitidis serogroup A, S. agalactiae, H. influenzae, HSV-2, L. monocytogenes serotype 1/2b, Parechovirus Type 3, VZV. FDA UDI
Identifiers
- Catalog Number
- NATMEC-BIO-IVD FDA UDI
- Primary DI / UDI-DI
- 01220000260498 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple-type meningitis-associated microorganism 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 meningitis-associated microorganism 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 e0a9396d-2595-4729-ab21-416196ea99a1 36 fields · synced Jun 7, 2026