QuickGel Accessory Kit - HELENA LABORATORIES CORPORATION

Duns Number:079396131

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More Product Details

Catalog Number

-

Brand Name

QuickGel Accessory Kit

Version/Model Number

3426

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

K982426

Product Code Details

Product Code

JBD

Product Code Name

SYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN

Device Record Status

Public Device Record Key

28719baa-8756-46cb-86d9-da34c6b1519b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

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