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NATtrol™

FDA UDI

Class I (US FDA UDI)

by ZeptoMetrix LLC

Identity

Trade Name
NATtrol™ FDA UDI
Generic Name
Mpox virus nucleic acid IVD, control FDA UDI
Device Name
NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Mpox virus nucleic acids. FDA UDI
Model / Reference
NATtrol™ Mpox Virus Negative Control FDA UDI
Description
NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Mpox virus nucleic acids. FDA UDI

Identifiers

Catalog Number
NATMPXVNEG-6C-IVD FDA UDI
Primary DI / UDI-DI
01220000260412 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Mpox virus 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: Mpox virus 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 Mpox virus nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZeptoMetrix LLC

Sources (1)

  • FDA UDI 61045d31-e3e5-452e-8586-56f7b747e63b 36 fields · synced Jun 8, 2026