QBC Diagnostics - Refurbished QBC STAR-I Centrifugal Hematology - DRUCKER DIAGNOSTICS

Duns Number:022156957

Device Description: Refurbished QBC STAR-I Centrifugal Hematology System: Refurbished QBC STAR-I Analyzer; QBC Refurbished QBC STAR-I Centrifugal Hematology System: Refurbished QBC STAR-I Analyzer; QBC Disposable Starter Kit (20 STAR Tubes)

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More Product Details

Catalog Number

42900209

Brand Name

QBC Diagnostics

Version/Model Number

42900209

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

Yes

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

-

FDA Premarket Submission

K992849,K992849

Product Code Details

Product Code

GKZ

Product Code Name

Counter, Differential Cell

Device Record Status

Public Device Record Key

8ece7a15-4e34-48cf-9c5b-0166f105ae98

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRUCKER DIAGNOSTICS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 351
2 A medical device with a moderate to high risk that requires special controls. 31