NATtrol™ - NATCT(434)-6MC is a qualitative in vitro - ZEPTOMETRIX CORPORATION

Duns Number:081586435

Device Description: NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be us NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays.

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More Product Details

Catalog Number

NATCT(434)-6MC

Brand Name

NATtrol™

Version/Model Number

NATtrol™ Chlamydia trachomatis (CT) Positive Control

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OHQ

Product Code Name

Multi-Analyte Controls Unassayed

Device Record Status

Public Device Record Key

6c4d52f7-aab8-4f93-a42c-d2db38047982

Public Version Date

June 21, 2021

Public Version Number

1

DI Record Publish Date

June 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEPTOMETRIX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 3