ARCHITECT - ARCHITECT AFP Reagent Kit - Abbott Ireland Diagnostics

Duns Number:985307301

Device Description: ARCHITECT AFP Reagent Kit

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More Product Details

Catalog Number

03P3625

Brand Name

ARCHITECT

Version/Model Number

3P36-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

LOK

Product Code Name

KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Device Record Status

Public Device Record Key

b361e6f0-0bd1-4eb6-a0a7-9bfa9a0da0b2

Public Version Date

May 10, 2021

Public Version Number

4

DI Record Publish Date

November 18, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT IRELAND DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 26
3 A medical device with high risk that requires premarket approval 47