Leica Biosystems

Primary DI
00849832028451
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
3803658
Catalog number
3803658
Device description
HistoCore FLASH H&E Staining System S3
Published
2026-10-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832028451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832028451008498320284518498320284510849832028451

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Regulatory Flags#

DUNS number
082930884
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10849832028465Leica Biosystems380173438017342026-10-21
10849832028472Leica Biosystems380015338001532026-10-21
00849832028345Leica Biosystems380365538036552026-10-13
10849832018619Leica Biosystems380077038007702026-10-13
10849832020360Leica Biosystems380079038007902026-10-13
10849832022968Leica Biosystems3800840E3800840E2026-10-13
10849832024122Leica Biosystems380078038007802026-10-13
10849832024153Leica Biosystems3800780AS3800780AS2026-10-13
10849832024306Leica Biosystems380081038008102026-10-13
10849832024368Leica Biosystems3800754AS3800754AS2026-10-13
10849832026904Leica Biosystems380084038008402026-10-13
20849832020343Leica Biosystems380081027AS380081027AS2026-10-13
20849832020350Leica Biosystems3800790BLK3800790BLK2026-10-13
20849832020695Leica Biosystems3800771BLK3800771BLK2026-10-13
20849832023092Leica Biosystems380075938007592026-10-13
20849832024105Leica Biosystems380079024AS380079024AS2026-10-13
20849832024112Leica Biosystems3800754BLK3800754BLK2026-10-13
20849832024396Leica Biosystems380075432AS380075432AS2026-10-13
20849832025676Leica Biosystems380077124AS380077124AS2026-10-13
00849832023036Leica Biosystems380085038008502026-10-12