FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832027819
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
3803200
Catalog number
3803200
Device description
Frostbite
Published
2026-05-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LEAPRESERVATIVE, CYTOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEAPreservative, CytologicalPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832027819PrimaryGS10
00849832027812Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983202781910849832027819
00849832027812008498320278128498320278120849832027812

GMDN Terms#

Term, Definition table
TermDefinition
General tissue specimen container IVD, fixative/salineA covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact tissue specimen sampling/excision devices. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
082930884
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
10849832001055Leica Biosystems39LC-705-439LC-705-42025-07-23
10849832003097Leica Biosystems39LC-705-339LC-705-32025-07-23
10849832024214Leica Biosystems380306538030652025-07-20
10849832024238Leica Biosystems380307538030752025-07-20
10849832024245Leica Biosystems380304538030452025-07-20
10849832024276Leica Biosystems380302538030252025-07-20
10849832025815Leica Biosystems39LC-705-139LC-705-12025-07-23
10849832025822Leica Biosystems39LC-705-239LC-705-22025-07-23
10849832025839Leica Biosystems39LC-705-539LC-705-52025-07-23
10849832027055Leica Biosystems380301538030152025-07-20
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410030PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410047PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410108PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410115PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410146PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410221PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410238PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410245PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410252PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410283PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410436PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410443PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410450PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410467PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410474PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410481PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
09551020410498PathTezt®BIOCYTECH CORPORATION SDN. BHD.LEA2026-03-11
00613647028629FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
20613647028623FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LEA2025-04-30
10849832002946Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00849832002949Leica BiosystemsLeica Biosystems Richmond, Inc.LEA2024-12-27
00810160180357SUPMEDICSupmedics Inc.LEA2024-11-04
00673693483032EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-10-22
00673693105279EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693105286EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230858EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693230865EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344692EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693344708EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-04
00673693088985EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEA2024-08-02