Catalog Number

3S-01-16003F

Brand Name

PRECICHEK AutoCode vial packed test strip

Version/Model Number

3S-01-16003F

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120064,K120064

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Public Device Record Key

8c78d28e-1e0a-4e6a-8617-dffc0c0c141a

Public Version Date

July 14, 2020

Public Version Number

1

DI Record Publish Date

July 06, 2020

Package DI Number

04260236851234

Quantity per Package

200

Contains DI Package

04260236850916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX