FDA.reportPublic FDA data

LW Scientific

Primary DI
00664816001769
Brand
LW Scientific
Company
LW SCIENTIFIC, INC.
Model
CTL-DIFD-08KP
Device description
8 Key Digital Differential Counter
Published
2019-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GHOHemocytometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GHOHemocytometerHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816001769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816001769006648160017696648160017690664816001769

GMDN Terms#

Term, Definition table
TermDefinition
Differential white blood cell count recorder IVD, poweredAn electrically-powered device intended to be used by a healthcare professional to manually record and display haematological cell counts of white blood cell populations in a clinical specimen, as observed under a microscope. It typically consists of buttons representing each white blood cell type (e.g., basophil, eosinophil, lymphocyte) which the operator depresses to record an observed cell type, and a screen to display each cell population count. It may also automatically calculate cell population percentages and allow for corrections in case of a miscount.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785335381
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00664816005897Qor LabsQLL-HRSD-10T3QLL-HRSD-10T32026-04-20
00664816005903Qor LabsQLL-HRDD-20T3QLL-HRDD-20T32026-04-20
00664816005316LW Scientific, Inc.Z4M-BZM7-EML3Z4M-BZM7-EML32026-04-17
00664816005323LW Scientific, Inc.Z4M-TZM7-EML3Z4M-TZM7-EML32026-04-17
00664816006030LW Scientific, Inc`E8C-C8AF-150PE8C-C8AF-150P2026-03-02
00664816006016LW ScientificM5C-BKT8-50A1M5C-BKT8-50A12026-02-20
00664816002322LW Scientific, IncICL-030L-D101ICL-030L-D1012026-02-19
00664816005682LW Scientific, Inc.MUC-08AT-15T3MUC-08AT-15T32026-02-16
00664816005699LW Scientific, Inc.DBL-40PL-02DPDBL-40PL-02DP2026-02-16
00664816005866LW Scientific, Inc.ROM-BN4A-IPL3ROM-BN4A-IPL32025-10-20
00664816005873LW Scientific, Inc.ELM-BN4A-IPL3ELM-BN4A-IPL32025-10-20
00664816005934LW Scientific, Inc.ROM-TN4A-IPL3ROM-TN4A-IPL32025-10-20
00664816005941LW Scientific, Inc.ELM -TN4A-IPL3ELM -TN4A-IPL32025-10-20
00664816005958LW Scientific, Inc.ASM-BN4A-IPL3ASM-BN4A-IPL32025-10-20
00664816005965LW Scientific, Inc.ASM-TN4A-IPL3ASM-TN4A-IPL32025-10-20
00664816001400LW Scientific, Inc.SHL-PPF7-06F1SHL-PPF7-06F12021-04-09
00664816003756LW Scientific, Inc`MMC-12MD-02T1MMC-12MD-02T12024-07-01
00664816005842LW Scientific, Inc.FWL-TISS-BTH3FWL-TISS-BTH32024-06-28
00664816005835LW ScientificZIC-06AD-15P3ZIC-06AD-15P32024-06-13
00664816001431LW Scientific, Inc.WBL-20LC-SSD1WBL-20LC-SSD12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14719874742338LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874742529LensHooke Prestained Morphology SlideBONRAYBIO CO., LTD.GHO2025-02-16
14719874743045LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742335LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
24719874742526LensHooke Prestained Morphology Slide BONRAYBIO CO., LTD.GHO2025-02-16
24719874743035LensHooke Semen Test SlideBONRAYBIO CO., LTD.GHO2025-02-16
00860010518199Fertility SolutionsFertility Solutions, Inc.GHO2023-10-30
08600105181998Fertility SolutionsFertility Solutions, Inc.GHO2023-09-15
86001051819986Fertility SolutionsFertility Solutions, Inc.GHO2023-09-15
00664816000212LW Scientific, Inc.LW SCIENTIFIC, INC.GHO2022-09-12
08809317540665C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540672C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540689C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540696C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540702C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540719C-ChipNanoEnTek, Inc.GHO2019-06-25
08809317540511C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540573C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540580C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540603C-ChipNanoEnTek, Inc.GHO2018-10-01
08809317540597C-ChipNanoEnTek, Inc.GHO2018-10-01
10805360018026MicroCellVITROLIFE INC.GHO2018-04-23
10805360018033MicroCellVITROLIFE INC.GHO2018-04-23
04061609000354Cover Slips (for Hemacytometer)BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000378Hemocytometer (CE) Fuchs-RosenthalBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000385Hemocytometer (CE) Fuchs-Rosenthal brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000392Hemocytometer (CE) Neubauer improvedBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000408Hemocytometer (CE) Neubauer improved brightlineBIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06
04061609000422Hemocytometer Neubauer improved, disposable, made of glass.BIOANALYTIC GmbH, biomed. AnalysentechnikGHO2018-02-06