30-slide vented carousel for Aerospray® - A 30-slide vented carousel to be used with - ELITECHGROUP INC.

Duns Number:052423787

Device Description: A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitat A 30-slide vented carousel to be used with Aerospray® stainer/cytocentrifuges to facilitate the staining of biological samples.

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More Product Details

Catalog Number

-

Brand Name

30-slide vented carousel for Aerospray®

Version/Model Number

AC-189

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

KPA

Product Code Name

Slide Stainer, Automated

Device Record Status

Public Device Record Key

fc847fb6-116c-4b1e-9976-bbf942f1b8d4

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELITECHGROUP INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 41