DEVICE: QBC Diagnostics (00858092006055)

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Device Identifier (DI) Information

QBC Diagnostics
42900109
42900109
DRUCKER DIAGNOSTICS
00858092006055
GS1
1
Refurbished QBC STAR-M Centrifugal Hematology System: Refurbished QBC STAR-M Analyzer; QBC Disposable Starter Kit (20 STAR Tubes)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
Yes
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Full blood count IVD, kit, cell count A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters [also known as complete blood count (CBC)] in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.
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FDA Product Code

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Product Code Product Code Name
GKZ Counter, Differential Cell
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
Yes
00858092006499
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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