Catalog Number

301041

Brand Name

APTIMA

Version/Model Number

APTIMA SWAB SPECIMEN COLLECTION KIT

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K003395,K003395

Product Code

LIO

Product Code Name

DEVICE, SPECIMEN COLLECTION

Public Device Record Key

6bcaaf8c-1eef-452d-934f-ef6c150a4443

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

April 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-