FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832020783
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801540
Device description
Hematoxylin Gill III
Published
2024-12-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HYJHEMATOXYLIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849832020783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849832020783008498320207838498320207830849832020783

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20849832016322Leica Biosystems380008138000812026-10-28
20849832016339Leica Biosystems380008238000822026-10-28
20849832016452Leica Biosystems380008338000832026-10-28
20849832023139Leica Biosystems380008038000802026-10-28
20849832023405Leica Biosystems380008538000852026-10-28
20849832023412Leica Biosystems380008638000862026-10-28
00849832004066Leica Biosystems CytoVision DM5500 for FL-Ergo Head23MIC550FXX0092016-09-17
00849832007920Leica Biosystems Ariol Fluorescent Unit23AXCITEDM2016-09-17
00849832007937Leica Biosystems Ariol UPS 110V23UPS22072016-09-17
00849832007944Leica Biosystems Ariol UPS 220V23UPS22082016-09-17
00849832009504Leica Biosystems Ariol MSCOPE Leica DM6000B BZ03 Ariol Multibay23MIC60042016-09-17
00849832009511Leica Biosystems Ariol Leica DM6000B Ariol23MIC60052016-09-17
00849832010333Leica Biosystems Ariol DM6000 B Basic Configuration Ariol23MIC12012016-09-17
00849832010340Leica Biosystems Ariol DM6000 B Basic Configuration Ariol Refurbished23MIC1201R2016-09-17
00849832010418Leica Biosystems Ariol DM6000 B Ariol PL20023MIC12062016-09-17
00849832010425Leica Biosystems Ariol DM6000 B for Ariol PL200 Refurbished23MIC1206R2016-09-17
00849832011361Leica Biosystems Ariol Beveled Edge Slide Holder23ASLSP0162016-12-02
00849832011576Leica Biosystems Ariol Cable, stage sensor23ASLSP0302017-03-29
00849832013204Leica ADAPTOR C14 TO C7, POWER SUPPLY23ADP00022017-10-13
00849832013228Leica Biosystems Slide Cassettes, SL20023ASLSP0032017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04015630972135Hematoxylin IIVentana Medical Systems, Inc.HYJ2025-12-15
B502BSB03601000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB036010000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360150Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB03602000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360500Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
08435421273498Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
08435804516624Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
00849832027171Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-20
00849832027041Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-19
10849832023064Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
20849832018081Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018087Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018049Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832022817Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
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00673693087926EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
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00673693483216EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
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00673693483230EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087971EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693087995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693088008EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03