LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1) - RANDOX LABORATORIES LIMITED

Duns Number:227530649

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More Product Details

Catalog Number

-

Brand Name

LIQUID CHEMISTRY PREMIUM PLUS - LEVEL 1 (LIQ CHEM PREMIUM PLUS 1)

Version/Model Number

LUL5093

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

Yes

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

OHQ

Product Code Name

Multi-Analyte Controls Unassayed

Device Record Status

Public Device Record Key

f808da08-63cb-429e-a608-da1ef9764048

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

June 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RANDOX LABORATORIES LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 305
2 A medical device with a moderate to high risk that requires special controls. 258