BACT/ALERT® 3D LEFT INCUBATION MODULE - the BacT/ALERT 3D Left Incubator Module has four - BIOMERIEUX , INC.

Duns Number:086785110

Device Description: the BacT/ALERT 3D Left Incubator Module has four independent drawers of 60 cells each. Pat the BacT/ALERT 3D Left Incubator Module has four independent drawers of 60 cells each. Patented cell flags track bottle movements between cells for greater ease of use.

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More Product Details

Catalog Number

-

Brand Name

BACT/ALERT® 3D LEFT INCUBATION MODULE

Version/Model Number

210159

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K903505,K981736

Product Code Details

Product Code

MDB

Product Code Name

System, blood culturing

Device Record Status

Public Device Record Key

10386246-bd03-453c-93a0-d187491f551f

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

October 23, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMERIEUX , INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 75