NOVA - NOVA 12, NOVA 14, NOVA 16 DILUTER PACK - NOVA BIOMEDICAL CORPORATION

Duns Number:070617139

Device Description: NOVA 12, NOVA 14, NOVA 16 DILUTER PACK

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More Product Details

Catalog Number

15819

Brand Name

NOVA

Version/Model Number

12

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K963005

Product Code Details

Product Code

JIX

Product Code Name

CALIBRATOR, MULTI-ANALYTE MIXTURE

Device Record Status

Public Device Record Key

e5325bad-28e6-49cf-805a-674d5d109c46

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVA BIOMEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 165
2 A medical device with a moderate to high risk that requires special controls. 210