AccessGUDID - DEVICE: NATtrol™ (01220000260177)

GUDID

Device Identifier (DI) Information

Brand Name: NATtrol™
Version or Model: NATtrol™ Enterovirus Negative Control
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NATEVNEG-6MC-IVD
Company Name: ZEPTOMETRIX CORPORATION

Primary DI Number: 01220000260177
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184020902 *Terms of Use

Device Description: The NATtrol™ Enterovirus (EV) 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™ EV 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48694	Enterovirus nucleic acid (serotypes 68-71) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple enteroviruses from serotypes 68-71 in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHQ	Multi-Analyte Controls Unassayed

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5354503d-36fd-477e-a6ce-56cd57bb3f79
Public Version Date: September 05, 2022
Public Version Number: 2
DI Record Publish Date: October 16, 2020