FDA.report

CELL-DYN

Primary DI
00380740004972
Brand
CELL-DYN
Company
ABBOTT LABORATORIES
Model
03H05-01
Catalog number
03H0501
Device description
CELL-DYN Immuno PLT (CD61)
Published
2016-06-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GKZCOUNTER, DIFFERENTIAL CELL

Product Code Classifications

CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00380740004972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740004972003807400049723807400049720380740004972

GMDN Terms

TermDefinition
Platelet count IVD, kit, cell countA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of platelet (thrombocyte) count in a clinical specimen using a manual, semi-automated or automated cell count method.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags

DUNS number
079226220
Device count
1
DM exempt
false
Premarket exempt
false
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 DIBrandModelCatalogPublished
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740023386ARCHITECT03M740103M74012026-01-24
00380740225155ARCHITECT04J622804J62282026-01-03
00380740225162ARCHITECT08G982808G98282026-01-03
00380740224523ARCHITECT04P552804P55282026-01-01
00380740224530ARCHITECT04P573204P57322026-01-01
00380740213565Alinity09P680209P68022025-12-25
00380740213572Alinity09P690209P69022025-12-25
00380740213558Alinity06U810106U81012025-09-25
00380740202958Alinity06P060706P06072025-09-24
00380740203061Alinity06P061506P06152025-09-24
00380740203078Alinity06P062506P06252025-09-24
00380740203092Alinity06P066106P06612025-09-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29
17290016991076HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
08809317540993ADAMNanoEnTek, Inc.GKZ2021-02-15
08809317541006ADAMNanoEnTek, Inc.GKZ2021-02-15
08809317540627ADAMNanoEnTek, Inc.GKZ2020-09-02
08809317540634ADAMNanoEnTek, 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
00382906642868BD FACSDiva™BECTON, DICKINSON AND COMPANYGKZ2020-05-05
00382906643452BD FACSDiva™BECTON, DICKINSON AND COMPANYGKZ2020-05-05
00382906641106BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08
00382906641120BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08
00382906641144BD FACSCanto™BECTON, DICKINSON AND COMPANYGKZ2020-04-08