Validate - Validate SARS-Cov2 IgG Single clinical chemistry - Lgc Clinical Diagnostics, Inc.

Duns Number:075886031

Device Description: Validate SARS-Cov2 IgG Single clinical chemistry analyte IVD, control

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More Product Details

Catalog Number

-

Brand Name

Validate

Version/Model Number

510mm

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

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

4d281ff4-01c7-4262-8a13-6a254eb08a00

Public Version Date

March 14, 2022

Public Version Number

3

DI Record Publish Date

February 09, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LGC CLINICAL DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 184
2 A medical device with a moderate to high risk that requires special controls. 39