ACID WASH SOLUTION (WASH SOLN. 3) - Acid Wash Solution should be used in conjunction - RANDOX LABORATORIES LIMITED

Duns Number:227530649

Device Description: Acid Wash Solution should be used in conjunction with reagents to clean probes and cuvette Acid Wash Solution should be used in conjunction with reagents to clean probes and cuvettes

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More Product Details

Catalog Number

RX8129

Brand Name

ACID WASH SOLUTION (WASH SOLN. 3)

Version/Model Number

RX8129

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)

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

JJE

Product Code Name

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Record Status

Public Device Record Key

c5f2bae8-15d5-428e-b93a-a8d2a92a9f41

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

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