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NATtrol™

FDA UDI

Class I (US FDA UDI)

by ZeptoMetrix LLC

Identity

Trade Name
NATtrol™ FDA UDI
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, control FDA UDI
Device Name
NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens. NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens. FDA UDI
Model / Reference
NATtrol™ RP Multimarker Controls FDA UDI
Description
NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens. NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens. FDA UDI

Identifiers

Catalog Number
MDZ001 FDA UDI
Primary DI / UDI-DI
01220000260016 FDA UDI
FDA Product Code
OHQ FDA UDI
GMDN Term
Multiple-type respiratory 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

No

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 respiratory 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 respiratory pathogen 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 abda68f4-efb1-46f1-9895-ddaf00e37349 36 fields · synced May 30, 2026