FDA.reportPublic FDA data

HemoScreen

Primary DI
17290016991076
Brand
HemoScreen
Company
PIXCELL MEDICAL TECHNOLOGIES LTD
Model
CBC Sampler
Catalog number
BC-MA-00100
Device description
A disposable unit used for the collection of the blood sample
Published
2022-07-19
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
true

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180020000HemoScreen Hematology AnalyzerPixcell Medical Technologies, Ltd.2018-10-29GKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290016991076PackageGS110In Commercial Distribution
27290016991073PackageGS125In Commercial Distribution
37290016991070PackageGS1100Not in Commercial Distribution
07290016991079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001699107617290016991076
2729001699107327290016991073
3729001699107037290016991070
07290016991079072900169910797290016991079

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection tube IVD, K2EDTAA non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature17 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature17 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532623092
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
07290016991062HemoCupHemoCup2019-05-27
07290016991086HemoScreenHemoScreen 2002024-09-02
07290016991000HemoScreenHemoScreen 2002019-01-14
07290016991079HemoScreenCBC SamplerBC-MA-001002022-07-19
07290016991048HemoScreenCBC SamplerBC-FA-002012019-01-14
07290016991017HemoScreenCBC CartridgeBC-FA-001032019-01-14
07290016991024HemoScreenCBC CartridgeBC-MA-003002019-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)Beckman Coulter, Inc.GKZ2026-05-19
00860008385888WBC Test StripAthelas, Inc.GKZ2026-04-28
00860008385871Athelas HomeAthelas, Inc.GKZ2026-04-27
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
00850063751216CitoCBC CartridgeCYTOCHIP INCGKZ2025-07-01
06944904002422BC-3200 Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.GKZ2025-01-17
04987562508440XQ-520 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2025-01-14
03610230009444Yumizen H2500HORIBA ABX SASGKZ2024-11-29
03610230009451Yumizen H2500HORIBA ABX SASGKZ2024-11-29
15099590762889Stem-Kit ReagentsBeckman Coulter, Inc.GKZ2024-10-25
15099590762896StemTrol Control CellsBeckman Coulter, Inc.GKZ2024-10-25
07290016991086HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2024-09-02
04987562503131XQ-320 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2024-05-24
00380740138851AlinityABBOTT LABORATORIESGKZ2023-11-16
00382906643438BD Trucount™Becton, Dickinson And CompanyGKZ2023-08-07
00382906654212FACSDivaBecton, Dickinson And CompanyGKZ2022-10-12
20860008385868Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29
07290016991079HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
08809317540993ADAM-rWBC HTNanoEnTek, Inc.GKZ2021-02-15
08809317541006ADAM-rWBC KitNanoEnTek, Inc.GKZ2021-02-15
08809317540627ADAMIINanoEnTek, Inc.GKZ2020-09-02
08809317540634ADAMII-CD34 KitNanoEnTek, Inc.GKZ2020-09-02
15099590671242DxH 500BECKMAN COULTER IRELAND INC.GKZ2020-08-31
15099590729110UniCel DxH 690T Coulter Cellular Analysis System Beckman Coulter, Inc.GKZ2020-08-31
00630414237909ADVIA 2120i Refurb w/o AutosamplerSiemens Healthcare Diagnostics Inc.GKZ2020-07-06