Access SARS-CoV-2 IgG II Calibrator - The Access SARS-CoV-2 IgG II Calibrators are - Beckman Coulter, Inc.

Duns Number:008254708

Device Description: The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 I The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization.

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More Product Details

Catalog Number

C69058

Brand Name

Access SARS-CoV-2 IgG II Calibrator

Version/Model Number

C69058

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

b2dd5d0f-4428-4b85-a18b-e6628d001772

Public Version Date

May 12, 2022

Public Version Number

1

DI Record Publish Date

May 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECKMAN COULTER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 319
2 A medical device with a moderate to high risk that requires special controls. 503
3 A medical device with high risk that requires premarket approval 9
U Unclassified 1