FDA.reportPublic FDA data

STROMATOLYSER-4DS

Primary DI
80664369201384
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
OTC
false
Sterile
false
Single use
false

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
690664461
Device count
3
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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

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Primary DI, Brand, Company table
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008171690247673D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKQC2022-12-29
10664369201385STROMATOLYSER-4DSSYSMEX CORPORATIONKQC2022-11-04
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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
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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
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00630414976327Diff-Quik™ Solution IISiemens Healthcare Diagnostics Products GmbHKQC2018-09-24
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03760177194557Ral Diff-Quik Solution II (1 x 2,5L)R.A.L. DIAGNOSTICSKQC2018-09-07
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