FDA.reportPublic FDA data

LW Scientific

Primary DI
00664816001141
Brand
LW Scientific
Company
LW SCIENTIFIC, INC.
Model
CTL-DIFM-05KY
Catalog number
CTL-DIFM-05KY
Device description
5 Key Differential Counter, manual
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
GLGPlatelet Counting, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GLGPlatelet Counting, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816001141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816001141006648160011416648160011410664816001141

GMDN Terms#

Term, Definition table
TermDefinition
Differential white blood cell count recorder IVD, non-poweredA non-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 consists of multiple mechanical tally counters with a lever representing each white blood cell type (e.g., basophil, eosinophil, lympocyte) which the operator depresses to record an observed cell type. Totals for population counts are displayed on the device and used to subsequently calculate the percentages for each population.

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
00192024068187Ricca Chemical Company®Ricca Chemical Company, LLCGLG2021-02-04
00192024068194Ricca Chemical Company®Ricca Chemical Company, LLCGLG2021-02-04
006648160035415-key Manual Differential CounterLW SCIENTIFIC, INC.GLG2019-06-24
006648160035588-key Manual Differential CounterLW SCIENTIFIC, INC.GLG2019-06-24
00664816001134LW Scientific LW SCIENTIFIC, INC.GLG2019-01-23