FDA.reportPublic FDA data

Research and Diagnostic Systems

Primary DI
00815762021138
Brand
Research and Diagnostic Systems
Company
RESEARCH AND DIAGNOSTIC SYSTEMS, INC.
Model
LRR001
Catalog number
LRR001
Device description
R&D LeukoReduced RBC Kit: 2 x 3mL (1 Low, 1 High)
Published
2016-07-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, Differential Cell

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815762021138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815762021138008157620211388157620211380815762021138

GMDN Terms#

Term, Definition table
TermDefinition
White blood cell count IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of 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 Volume6Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-428-4246customerserviceccd@bio-techne.com

Regulatory Flags#

DUNS number
087248183
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815762020490Research and Diagnostic SystemsPIX0022025-12-01
00815762023446Research and Diagnostic Systems0CP010TA32025-12-01
00815762023453Research and Diagnostic Systems0CP020TA32025-12-01
00815762026362Research and Diagnostic SystemsXN004XN0042025-06-06
00815762026508Research and Diagnostic SystemsCL037CL0372025-06-04
00815762020520R&D CBC-XR Hematology ControlXR0102024-04-02
00815762020537R&D CBC-XR Hematology ControlXR0042024-04-02
00815762020605R&D CBC-XR Hematology ControlXR0022024-04-02
00815762026331R&D CBC-DH Hematology ControlDH002DH0022023-06-30
00815762026348R&D CBC-DH Hematology ControlDH004DH0042023-06-30
00815762021978R & D Systems, Inc. CBC-PIX Hematology ControlP0022018-12-05
20815762020340Research and Diagnostic Systems72001X72001X2016-07-29
20815762020937Research and Diagnostic Systems3KC123KC122016-07-29
20815762020951Research and Diagnostic SystemsGH00HXGH00HX2016-07-29
20815762020975Research and Diagnostic SystemsGH00LXGH00LX2016-07-29
20815762020999Research and Diagnostic SystemsGH00NXGH00NX2016-07-29
00815762020056Research and Diagnostic SystemsBF001BF0012016-08-03
00815762020063Research and Diagnostic SystemsBF002BF0022016-08-03
00815762020070Research and Diagnostic SystemsBFI001BFI0012016-08-03
00815762020087Research and Diagnostic SystemsBFI002BFI0022016-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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