QuickScan 2000 Windows Software & Key - HELENA LABORATORIES CORPORATION

Duns Number:836287433

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More Product Details

Catalog Number

-

Brand Name

QuickScan 2000 Windows Software & Key

Version/Model Number

1673000

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

-

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

JQJ

Product Code Name

DENSITOMETERIC, PROTEIN FRACTIONATION

Device Record Status

Public Device Record Key

be1cfb27-f76e-4ec9-ad93-7c0e4c25718d

Public Version Date

September 16, 2022

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