ARCHITECT - SARS-CoV-2 IgG Reagent Kit 100 Tests - ABBOTT LABORATORIES

Duns Number:079226220

Device Description: SARS-CoV-2 IgG Reagent Kit 100 Tests

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More Product Details

Catalog Number

06R8620

Brand Name

ARCHITECT

Version/Model Number

06R8620

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

QKO

Product Code Name

Reagent, coronavirus serological

Device Record Status

Public Device Record Key

3c6bc3f7-e7ca-4b19-a1a7-a4d322f91210

Public Version Date

June 09, 2020

Public Version Number

2

DI Record Publish Date

May 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT LABORATORIES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 259
2 A medical device with a moderate to high risk that requires special controls. 245
U Unclassified 5