Catalog Number

95413

Brand Name

OPTIGEN® AP 3600™ Automated Instrument

Version/Model Number

95413

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

-

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

K182793

Product Code

DHB

Product Code Name

System, test, radioallergosorbent (rast) immunological

Public Device Record Key

d60daf39-4097-4f5f-80aa-06c5811136f2

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

May 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-