Catalog Number

PRD-04843

Brand Name

Aptima

Version/Model Number

AC2, 250T, RMR, (RT)

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

K132251

Product Code

LSL

Product Code Name

DNA-REAGENTS, NEISSERIA

Public Device Record Key

ba671055-e58f-4b23-90ae-2c94362fe9fc

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

September 26, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-