FDA.reportPublic FDA data

Horizon 24 Flex Centrifuge, Dr. PRP, Universal Rotor (4)

Primary DI
00810052862781
Brand
Horizon 24 Flex Centrifuge, Dr. PRP, Universal Rotor (4)
Company
DRUCKER DIAGNOSTICS
Model
00-389-107-001
Catalog number
00-389-107-001
Device description
General purpose laboratory centrifuge for sample separation.
Published
2021-09-03
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

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
00810052862781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810052862781008100528627818100528627810810052862781

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810052864945642M Centrifuge, AccuReference00-077-241-00000-077-241-0002026-02-02
00810052864938TrueBond Set 3 Centrifuge, Zoetis00-276-226-00000-276-226-0002026-01-15
00810052864914DASH Coag Centrifuge, CME, Tall Rotor, Platform Mount00-676-252-00000-676-252-0002025-12-17
00810052864921DASH Flex 6 DC Centrifuge, CME, Platform Mount00-176-252-00000-176-252-0002025-12-17
00810052864907TrueBond Duet Centrifuge, Pivetal00-056-256-00000-056-256-0002025-12-15
00810052864891Boost 2 Flex DC Centrifuge, Oyasama00-876-300-00000-876-300-0002025-12-04
00810052864785Boost 4 Centrifuge, Drucker00-289-009-00000-289-009-0002025-09-25
00810052864792642M Centrifuge, CardinalCA077104CA0771042025-09-25
00810052864808DASH Flex 6 Centrifuge, Cardinal, PlatformCA176104CA1761042025-09-25
00810052864778DASH Apex 4 Centrifuge, CardinalCA053104CA0531042025-08-25
00810052864761614B Centrifuge, Center Point Bio-Tech00-004-296-00000-004-296-0002025-08-15
00810052864747Centrio Centrifuge00-050-294-00000-050-294-0002025-06-18
00810052864754Horizon 24 Centrifuge, Quest00-284-032-00000-284-032-0002025-06-09
00810052864723Horizon 6 Flex DC Centrifuge, Alvedia, TrueBond00-376-258-00000-376-258-0002025-04-28
00810052864716Horizon 6 Flex (DC) Centrifuge, Svenska Labex00-376-289-00000-376-289-0002025-04-10
00810052864594DASH Apex 4 Centrifuge, Medline00-053-215-00000-053-215-0002025-04-05
00810052864709Boost 4+ Flex Centrifuge, Bioventus, Platform Mount00-389-290-00000-389-290-0002025-03-27
00810052864693642E Centrifuge, Access Medical Labs00-018-271-00000-018-271-0002025-03-17
00810052864686DASH Flex 6 Centrifuge, Medline00-176-215-00000-176-215-0002025-03-04
00810052864662Horizon 24 Flex Centrifuge, HealthLabs00-384-273-00000-384-273-0002025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840095681674Globe ScientificGLOBE SCIENTIFIC INC.JQC2026-03-16
10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310293Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310378Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310392Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310484Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310491Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
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
00810052864945642M Centrifuge, AccuReferenceDRUCKER DIAGNOSTICSJQC2026-02-02
00810052864938TrueBond Set 3 Centrifuge, ZoetisDRUCKER DIAGNOSTICSJQC2026-01-15
G668FG0020ASCENT FLEXXBMCORTHOASCENT, LLCJQC2026-01-05
G668FG0021ASCENT FLEXXBMCORTHOASCENT, LLCJQC2026-01-05
G668FG0160BMC Device MasterpackORTHOASCENT, LLCJQC2026-01-05
00810052864914DASH Coag Centrifuge, CME, Tall Rotor, Platform MountDRUCKER DIAGNOSTICSJQC2025-12-17
00810052864921DASH Flex 6 DC Centrifuge, CME, Platform MountDRUCKER DIAGNOSTICSJQC2025-12-17
00810052864907TrueBond Duet Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2025-12-15
00810052864891Boost 2 Flex DC Centrifuge, OyasamaDRUCKER DIAGNOSTICSJQC2025-12-04
10850044310033Thermo ScientificThermo Electron LED GmbHJQC2025-12-01
10850044310149Thermo ScientificThermo Electron LED GmbHJQC2025-12-01
10850044310170Thermo ScientificThermo Electron LED GmbHJQC2025-12-01
10850044310187Thermo ScientificThermo Electron LED GmbHJQC2025-12-01
10850044310507Thermo ScientificThermo Electron LED GmbHJQC2025-12-01
00810052864785Boost 4 Centrifuge, DruckerDRUCKER DIAGNOSTICSJQC2025-09-25
00810052864792642M Centrifuge, CardinalDRUCKER DIAGNOSTICSJQC2025-09-25
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