NATtrol™ Chlamydia trachomatis Positive Control Pack

EUDAMEDFDA UDI

Class B (EU MDR)

Ref NATCSO-6MC-IVD

by ZeptoMetrix LLC

Identity

Trade Name: NATtrol™ FDA UDI
Generic Name: Clostridium difficile nucleic acid IVD, control FDA UDI
Device Name: NATtrol™ Chlamydia trachomatis Positive Control Pack EUDAMED
The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. 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 errors. NATtrol™ Clostridium difficile Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. FDA UDI
Model / Reference: NATCSO-6MC-IVD EUDAMED
NATtrol™ Clostridium difficile Negative Control FDA UDI
Description: The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. 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 errors. NATtrol™ Clostridium difficile Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. FDA UDI

Identifiers

Catalog Number: NATCSO-6MC-IVD FDA UDI
Primary DI / UDI-DI: 01220000260061 EUDAMEDFDA UDI
Basic UDI-DI: 122000026NATERCK5 EUDAMED
FDA Product Code: OHQ FDA UDI
EMDN Code: W0105011804 C.DIFFICILE BY NA REAGENTS EUDAMED
GMDN Term: Clostridium difficile nucleic acid IVD, control FDA UDI

Classification

Device Class: Class B EUDAMED
Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Market of Registration: Northern Ireland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

NATtrol™ Chlamydia trachomatis Positive Control Pack by ZeptoMetrix LLC — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	122000026NATERCK5	Class B	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class B	Pending data

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Manufacturer

Manufacturer: ZeptoMetrix LLC
EUDAMED SRN: US-MF-000035245
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (2)

EUDAMED 6d4dc666-54f4-4ca8-8e43-3299caded16e 61 fields · synced Jun 18, 2026
FDA UDI 53adaedf-c69a-4aea-a3f1-caa7e11aea84 36 fields · synced May 30, 2026