BioPlex 2200 - APLS IgG, IgM and IgA Assay Protocol File CD, - BIO-RAD LABORATORIES, INC.

Duns Number:884513334

Device Description: APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only

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More Product Details

Catalog Number

6651975B

Brand Name

BioPlex 2200

Version/Model Number

SW4.1V1

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)

-

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

MID

Product Code Name

SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL

Device Record Status

Public Device Record Key

51fd47da-b778-44e5-ac7e-24f777515925

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 12, 2016

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