FDA.report

Horizon 6 Flex FA Centrifuge, Medira

Primary DI
00810052863252
Brand
Horizon 6 Flex FA Centrifuge, Medira
Company
DRUCKER DIAGNOSTICS
Model
00-376-111-005
Catalog number
00-376-111-005
Device description
General purpose laboratory centrifuge for sample separation.
Published
2022-05-20
Public version status
New
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
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810052863252PrimaryGS10

GMDN Terms

TermDefinition
General-purpose tabletop centrifugeA tabletop- or bench-mounted mains electricity (AC-powered) device used mainly in the clinical laboratory to separate the components of suspensions through low- or medium-speed centrifugal force (typically up to 6,000 or 12,000 rpm). It is typically a compact stationary structure with an electric motor, a vertical shaft, and a horizontal rotor attached to the upper end. This device is mostly used to centrifuge various patient samples (i.e., body fluids), either alone or after addition of reagents or other additives before measuring analytes.

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
true
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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