FDA.reportPublic FDA data

STROMATOLYSER-4DS

Primary DI
10664369201385
Brand
STROMATOLYSER-4DS
Company
SYSMEX CORPORATION
Model
FFS-800A
Device description
Stain reagent for hematology analyzers
Published
2022-11-04
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
KQCStains, Hematology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQCStains, HematologyHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10664369201385PrimaryGS10
80664369201384Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1066436920138510664369201385
8066436920138480664369201384

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume42Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00DO NOT FREEZE
Storage Environment Temperature2 Degrees Celsius35 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
690664461
Device count
3
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration 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
14719874742901LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.KQC2025-02-16
14719874742918LensHooke Sperm Double Strand DNA Fragmentation Rapid Test Kit (SDFR assay)BONRAYBIO CO., LTD.KQC2025-02-16
008171690247673D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKQC2022-12-29
80664369201384STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
15099590204143COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590204150COULTER TruColor Wright-Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590204167COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250706COULTER TruColor Wright StainBeckman Coulter, Inc.KQC2020-08-31
15099590250713COULTER TruColor Wright- Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
15099590250720COULTER TruColor Wright Stain Buffer Beckman Coulter, Inc.KQC2020-08-31
15099590250737COULTER TruColor Wright- Giemsa Stain BufferBeckman Coulter, Inc.KQC2020-08-31
15099590250744COULTER TruColor May Grünwald StainBeckman Coulter, Inc.KQC2020-08-31
15099590250751COULTER TruColor Giemsa StainBeckman Coulter, Inc.KQC2020-08-31
00630414976310Diff-Quik™ Solution ISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414976327Diff-Quik™ Solution IISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992617Diff-Quik™ Stain SetSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
00630414992624Diff-Quik™ FixativeSiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
03760177194519Ral Diff-Quik EZ-Kit (3 x 100ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194526Ral Diff-Quik Kit (3 x 500ml)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194533Ral Diff-Quik Fixative Solution (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194540Ral Diff-Quik Solution I (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
03760177194557Ral Diff-Quik Solution II (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
00812117015897FluoroQuench Acridine Orange/Ethidium Bromide - 100mlONE LAMBDA, INC.KQC2018-05-31
00812117016184FluoroQuench Acridine Orange/Ethidium Bromide - 500mlONE LAMBDA, INC.KQC2018-05-31
00812117016207FluoroQuench Acridine Orange/Ethidium Bromide - 2000 mlONE LAMBDA, INC.KQC2018-05-31
00812117018447FluoroQuench Plus Acridine Orange/Ethidium Bromide - 100 mlONE LAMBDA, INC.KQC2018-05-31
00691573200005CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10
00691573210035CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10
00691573211032CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10
00691573400009CamcoCAMBRIDGE DIAGNOSTIC PRODUCTS INCKQC2017-03-10