CueSee® CO-OX - CueSee® CO-OX LVA is an assayed quality control - Eurotrol B.V.

Duns Number:412925992

Device Description: CueSee® CO-OX LVA is an assayed quality control material for professional use to verify th CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory).CueSee® CO-OX LVA contains: 1 bottle of CueSee® CO-OX S1A (DI: 08718734961000), 1 bottle of CueSee® CO-OX S2A (DI: 08718734961017), 1 bottle of CueSee® CO-OX S3A (DI: 08718734961024), 1 bottle of CueSee® CO-OX S4A (DI: 08718734961031) and 1 bottle of CueSee® CO-OX S5A (DI: 08718734961048).

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More Product Details

Catalog Number

AN01486A04

Brand Name

CueSee® CO-OX

Version/Model Number

LVA

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)

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

GGM

Product Code Name

Control, Hemoglobin

Device Record Status

Public Device Record Key

a3cd069a-4ea2-4e7c-b680-f40dc4b06885

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EUROTROL B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 15