BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL) - RANDOX LABORATORIES LIMITED

Duns Number:227530649

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More Product Details

Catalog Number

-

Brand Name

BETA 2 MICROGLOBULIN CALIBRATOR (B2M CAL)

Version/Model Number

BM1362

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

JIT

Product Code Name

Calibrator, Secondary

Device Record Status

Public Device Record Key

066d70f5-e8c3-40f4-add9-9ef9470d9bca

Public Version Date

October 10, 2022

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