Catalog Number

47486

Brand Name

NOVA

Version/Model Number

STATSTRIP LAC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112955,K112955,K112955

Product Code

KHP

Product Code Name

ACID, LACTIC, ENZYMATIC METHOD

Public Device Record Key

bd43dad3-6209-4b3a-9be8-1ab272bb3ca4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

20385480474867

Quantity per Package

2

Contains DI Package

10385480474860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton