LIPID CALIBRATOR, LYOPHILIZED - LIPID CALIBRATOR, LYOPHILIZED - CLINIQA CORPORATION

Duns Number:078742335

Device Description: LIPID CALIBRATOR, LYOPHILIZED

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More Product Details

Catalog Number

-

Brand Name

LIPID CALIBRATOR, LYOPHILIZED

Version/Model Number

R85528

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)

-

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

a565b63e-1e96-498b-9086-24f72a410e9d

Public Version Date

February 04, 2019

Public Version Number

2

DI Record Publish Date

August 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLINIQA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 4