BioPlex 2200 - BioPlex 2200 25-OH Vitamin D Calibrator Lot Data - BIO-RAD LABORATORIES, INC.

Duns Number:884513334

Device Description: BioPlex 2200 25-OH Vitamin D Calibrator Lot Data

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More Product Details

Catalog Number

12006553

Brand Name

BioPlex 2200

Version/Model Number

12006553

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

JIT

Product Code Name

Calibrator, secondary

Device Record Status

Public Device Record Key

7b423c5a-3592-4bc0-a949-7f5c5a25a855

Public Version Date

January 23, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIO-RAD LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 511
2 A medical device with a moderate to high risk that requires special controls. 428
U Unclassified 1