Anti-SARS-CoV-2 S1 Curve ELISA (IgG) - EUROIMMUN Medizinische Labordiagnostika AG

Duns Number:322209263

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More Product Details

Catalog Number

-

Brand Name

Anti-SARS-CoV-2 S1 Curve ELISA (IgG)

Version/Model Number

EI 2606-9601-20 G

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

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

-

Product Code Details

Product Code

QKO

Product Code Name

Reagent, Coronavirus Serological

Device Record Status

Public Device Record Key

d1afde3e-9b53-4866-8f23-1666211f13c8

Public Version Date

November 02, 2021

Public Version Number

1

DI Record Publish Date

October 25, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 115
2 A medical device with a moderate to high risk that requires special controls. 213