Catalog Number

LKAP1

Brand Name

IMMULITE®/IMMULITE®1000 Systems AF AFP

Version/Model Number

10381162

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

P010007,P010007,P010007,P010007

Product Code

LOK

Product Code Name

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

Public Device Record Key

ae07d37a-690c-4a0f-8c3b-3cd8bd3307ed

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-