FDA.reportPublic FDA data

ADAMII-CD34 Kit

Primary DI
08809317540634
Brand
ADAMII-CD34 Kit
Company
NanoEnTek, Inc.
Model
CD34K-050
Catalog number
CD34K-050
Device description
ADAMII-CD34 Kit provides enumeration of viable CD34+ cells, viable CD45+ cells, and calculates percentage of viable CD34+ cells out of viable CD45+ cells. ADAMII-CD34 Kit can be used for mobilized peripheral blood (MPB) collected in Na-Heparin or EDTA, haematopoietic progenitor cell – apheresis (HPC-A) collected in ACD or ACD+Heparin, fresh cord blood (FCB) collected in CPD, and thawed frozen cord blood (TFCB) collected in CPD and stored with 10% DMSO, 1% Dextran 40.
Published
2020-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
BK1802830

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK1802830

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809317540634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809317540634088093175406348809317540634

GMDN Terms#

Term, Definition table
TermDefinition
CD34 cell marker IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD34 cell marker in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687910463
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809317540252ADAM-rWBCADAM-rWBC ADAM-rWBC2018-06-11
08809317540269ADAM-rWBC KitAD1K-050AD1K-0502016-09-30
08809317540276ADAM-rWBC SystemADAM-rWBC SystemADAM-rWBC System2016-09-30
08809317540498ADAM-rWBC2ADAM-rWBC2ADAM-rWBC22018-06-19
08809317540504ADAM-rWBC2 SystemADAM-rWBC2 SystemADAM-rWBC2 System2018-06-19
08809317540207FREND SystemF102018-05-04
08809317540153FREND TestosteroneFRTE-HBFRTE 0202016-11-28
08809317540375FREND TestosteroneFRTE-APFRTEAP 0202018-05-04
08809317540467FREND APF10AP2018-06-11
08809317541143r-Control RBC and PLTADRCADRC 0202021-12-08
08809317540993ADAM-rWBC HTADAM-rWBC HTADAM-rWBC HT2021-02-15
08809317541006ADAM-rWBC KitADHK-050ADHK-0502021-02-15
08809317540528FREND Free T4 Linearity KitFLK-FT42018-10-01
08809317540559FREND TSH Linearity KitFLK-TSH2018-10-01
08809317540566FREND Vitamin D Linearity KitFLK-VTD2018-10-01
08809317540627ADAMIIADAMII2020-09-02
08809317540917COVID-19 total Ab Control LQFIC-COALQFIC-COALQ2020-09-02
08809317540924FREND COVID-19 total AbFREND COVID-19 total AbFRCOA 0202020-09-02
08809317540825FREND Blocking ReagentFRBR 015FRBR 0152020-03-24
08809317540016FREND TSHFRTS 025FRTS 0252016-09-30

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
17290016991076HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
08809317540993ADAM-rWBC HTNanoEnTek, Inc.GKZ2021-02-15
08809317541006ADAM-rWBC KitNanoEnTek, Inc.GKZ2021-02-15
08809317540627ADAMIINanoEnTek, 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