FDA.reportPublic FDA data

MIKRO 200 Robotic

Primary DI
04050674075916
Brand
MIKRO 200 Robotic
Company
Andreas Hettich GmbH & Co. KG
Model
MIKRO 220 Robotic 200-240V/50-60Hz
Catalog number
2350
Device description
Tabletop centrifuge, automated
Published
2021-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050674075916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050674075916040506740759164050674075916

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
316403245
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04050674022910Slide carrier1-place16622021-09-03
04050674024587Carrier4-place14672021-09-03
04050674026055Bucket4285-A4285-A2021-09-03
04050674026062Bucket4299-N4299-N2021-09-03
04050674026093Bucket425742572021-09-03
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04050674026147Bucket425242542021-09-03
04050674026284Bucket142514252021-09-03
04050674026338Bucket142714272021-09-03
04050674026345Bucket145214522021-09-03
04050674026383Bucket166016602021-09-03
04050674026529Bucket175217522021-09-03
04050674026550Bucket509250922021-09-03
04050674026574Bucket505150512021-09-03
04050674026598Bucket168016802021-09-03
04050674026703Bucket139813982021-09-03
04050674026772Bucket1453-A1453-A2021-09-03
04050674026840Bucket562856282021-09-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02
00664816006016LW ScientificLW SCIENTIFIC, INC.JQC2026-02-20
00664816005682LW Scientific, Inc.LW SCIENTIFIC, INC.JQC2026-02-16
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00810052864907TrueBond Duet Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2025-12-15
00810052864891Boost 2 Flex DC Centrifuge, OyasamaDRUCKER DIAGNOSTICSJQC2025-12-04
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00810052864808DASH Flex 6 Centrifuge, Cardinal, PlatformDRUCKER DIAGNOSTICSJQC2025-09-25
00810052864778DASH Apex 4 Centrifuge, CardinalDRUCKER DIAGNOSTICSJQC2025-08-25
00810052864761614B Centrifuge, Center Point Bio-TechDRUCKER DIAGNOSTICSJQC2025-08-15