FDA.reportPublic FDA data

LW Scientific, Inc.

Primary DI
00664816002292
Brand
LW Scientific, Inc.
Company
LW SCIENTIFIC, INC.
Model
I4S-EPB4-ISL3
Catalog number
I4S-EPB4-ISL3
Device description
I-4 Infinity Epi-fluorescent Microscope, SEMI-PLAN, binocular, LED, (LED 485nm)
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IBKMicroscope, Fluorescence/U.V.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBKMicroscope, Fluorescence/U.V.Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00664816002292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00664816002292006648160022926648160022920664816002292

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescence light microscopeA magnification instrument in which light (typically ultraviolet) that has been absorbed by the specimen and re-emitted at a longer wavelength is observed (as visible light) so that the specimen is visible through the eyepiece. This device is typically used in the laboratory for histopathology and microbiology, commonly in conjunction with fluorescent dyes. Appropriate filters are used to select the correct wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incident wavelength from the fluorescent light source (i.e., the specimen).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
785335381
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
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

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04049016159018UNIQO 160EUROIMMUN Medizinische Labordiagnostika AGIBK2023-09-20
00664816001943LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816001950LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816001967LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002261LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
00664816002278LW Scientific, Inc.LW SCIENTIFIC, INC.IBK2023-06-27
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05700574035105LLX-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037062LFXBIOAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037291LFXW-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01
05700574037307LLXW-SIAGILENT TECHNOLOGIES, INC.IBK2022-05-01