DEVICE: QBC Diagnostics (00858092006031)

Device Identifier (DI) Information

QBC Diagnostics
425740
In Commercial Distribution
425740
DRUCKER DIAGNOSTICS
00858092006031
GS1

1
022156957 *Terms of Use
QBC Centrifuge - Capillary Tube Centrifuge
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
32429 Microhaematocrit centrifuge IVD
An electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.
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36465 General-purpose centrifuge IVD
An electrically-powered device intended to be used to separate the components of multiple types and various volumes of clinical suspensions using centrifugal force. It is a self-contained unit with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. It is typically used to centrifuge various types of clinical specimens, either alone or after addition of reagents or other additives, for subsequent in vitro diagnostic analysis. It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.
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FDA Product Code

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Product Code Product Code Name
GKG Centrifuge, Hematocrit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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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 Record Status

ef65c50a-66bc-46c4-aec5-d89f4860478b
October 25, 2023
4
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
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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