Identity
- Trade Name
- NATtrol™ FDA UDI
- Generic Name
- Beta-haemolytic Group A Streptococcus nucleic acid IVD, control FDA UDI
- Device Name
- NATtrol™ Strep A Positive Control (NATSPY-6MC-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Streptococcus pyogenes nucleic acids. FDA UDI
- Model / Reference
- NATtrol™ Strep A Positive Control FDA UDI
- Description
- NATtrol™ Strep A Positive Control (NATSPY-6MC-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Streptococcus pyogenes nucleic acids. FDA UDI
Identifiers
- Catalog Number
- NATSPY-6MC-IVD FDA UDI
- Primary DI / UDI-DI
- 01220000260450 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Beta-haemolytic Group A Streptococcus 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: Beta-haemolytic Group A Streptococcus 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 Beta-haemolytic Group A Streptococcus nucleic acid IVD, control.
- Simplexa™ Group A Strep Positive Control Pack — DiaSorin Molecular LLC · Class II
- ID NOW Strep A 2 Control Swab Kit — Alere Scarborough, Inc. · Class II
- cobas® Strep A Quality Control Kit for use on the cobas® Liat® System — Roche Molecular Systems, Inc. · Class II
- Panther Fusion® — Hologic, Inc. · Class I
- NATtrol™ — ZeptoMetrix LLC · Class I
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 5f0ad5f7-0bf9-403f-b0fa-e808e83cd524 36 fields · synced May 30, 2026