VIROTROL - VIROTROL SARS-CoV-2 (An unassayed (human) - BIO-RAD LABORATORIES, INC.

Duns Number:051624070

Device Description: VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)

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More Product Details

Catalog Number

200300A

Brand Name

VIROTROL

Version/Model Number

200300A

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

OHQ

Product Code Name

Multi-analyte controls unassayed

Device Record Status

Public Device Record Key

831dde1f-dd1e-4bf4-88e3-30344879c658

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1