FDA.report

QBC Diagnostics

Primary DI
00858092006031
Brand
QBC Diagnostics
Company
DRUCKER DIAGNOSTICS
Model
425740
Catalog number
425740
Device description
QBC Centrifuge - Capillary Tube Centrifuge
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GKGCentrifuge, Hematocrit

Product Code Classifications

CodeDeviceSpecialtyClass
GKGCentrifuge, HematocritHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00858092006031PrimaryGS10

GMDN Terms

TermDefinition
Microhaematocrit centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to process through high-speed centrifugal force (typically 10,000 to 25,000 rpm) specimens of whole blood to determine the ratio of the red cell volume to the whole blood volume expressed as a decimal, fraction, or percentage. The device typically generates a relative centrifugal force (RCF) of at least 10,000 x g to efficiently pack cells in a short time (i.e., 3 to 5 minutes) and requires a smaller sample size than low-speed conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal.

Sterilization Methods

Method

Regulatory Flags

DUNS number
022156957
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04050674027663Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
04050674027748Angle rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
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04050674030151Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02
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04050674077316Swing-out rotorAndreas Hettich GmbH & Co. KGGKG2021-09-02