FDA.reportPublic FDA data

Sample Preparation System PS-10

Primary DI
04987562501908
Brand
Sample Preparation System PS-10
Company
SYSMEX CORPORATION
Model
PS-10
Device description
The Sample Preparation System PS-10 is a fully automated, user-configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers.
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987562501908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987562501908049875625019084987562501908

GMDN Terms#

Term, Definition table
TermDefinition
Pipetting system IVDAn electrically-powered, software-operated instrument intended to be used in the laboratory to withdraw, transfer, and/or inject volumes of fluid materials, typically from one laboratory container to another, during an in vitro diagnostic procedure. The device is programmable to allow for automated single and/or multichannel fluid handling and delivery of user-specified volumes into a single container or multiple containers (e.g., microplate) simultaneously. It has no other specimen processing capabilities.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)879-7639crc@sysmex.com

Regulatory Flags#

DUNS number
690664461
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987562516797CA CAL S014-1271-42024-02-22
04987562205936CA CAL S014127142017-10-06
00664369000899LYSERCELL WDF IICY754019ZA9000142026-04-24
04987562408528UF II CONTROL064041152022-11-30
04987562499700Automated Blood Coagulation Analyzer CN-3000CL971029CL9710292025-12-19
04987562518616Automated Blood Coagulation Analyzer CN-3000BN343315CL9710292025-12-19
14987562460264EIGHTCHECK-3WP140-3004-02016-08-05
14987562460387RANGE CHECK X lll2189812016-08-05
14987562460608plt-CHECK200-4004-02017-10-06
14987562460615plt-CHECK200-4004-12017-10-06
04987562518654Automated Blood Coagulation Analyzer CS-5100CU624138BY9907572024-02-22
04987562518661Automated Blood Coagulation Analyzer CS-2500AG528355BV9817982024-02-22
04987562518678Automated Blood Coagulation Analyzer CA-600 series CA-620CM217273BR1426262024-02-22
04987562518685Automated Blood Coagulation Analyzer CA-600 series CA-660CA174898CK9782892024-02-22
04987562425426Automated Blood Coagulation Analyzer CS-5100BY990757BY9907572016-08-05
04987562425686Automated Blood Coagulation Analyzer CA-600 series CA-620BR142626BR1426262016-08-04
04987562425716Automated Blood Coagulation Analyzer CA-600 series CA-660CK978289CK9782892016-08-05
04987562433735Automated Blood Coagulation Analyzer CS-2500BV981798BV9817982016-09-16
04987562499687Automated Blood Coagulation Analyzer CN-6000CV339763CV3397632025-08-22
04987562518630Automated Blood Coagulation Analyzer CN-6000AX801645CV3397632025-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590750312CellmekBeckman Coulter, Inc.PER2025-09-02
00382906663405BD FACSDuetBecton, Dickinson And CompanyPER2023-06-12
00382906631282BD FACSDuetBecton, Dickinson And CompanyPER2022-08-23
00382906641144FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641168FACSBecton, Dickinson And CompanyPER2020-04-08
00382906641199FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641229FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906577658FACSBecton, Dickinson And CompanyPER2019-02-13
15099590563547TQ-Prep WorkstationBeckman Coulter, Inc.PER2016-09-23
15099590638191PrepPlus 2Beckman Coulter, Inc.PER2016-09-23
00382906466006BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08
00382906466020BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08
00382906472052FACSBecton, Dickinson And CompanyPER2016-06-08