V8 SP Normal Control (10 x 2 mL) - HELENA LABORATORIES CORPORATION

Duns Number:079396131

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More Product Details

Catalog Number

-

Brand Name

V8 SP Normal Control (10 x 2 mL)

Version/Model Number

1810

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131479

Product Code Details

Product Code

JJY

Product Code Name

Multi-analyte controls, all kinds (assayed)

Device Record Status

Public Device Record Key

288d6559-fd79-43e0-a38d-3f3b5e22d034

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HELENA LABORATORIES CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 152
2 A medical device with a moderate to high risk that requires special controls. 214