FDA.reportPublic FDA data

Leica Biosystems

Primary DI
20849832020343
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
380081027AS
Catalog number
380081027AS
Device description
60 mL Prefilled Affirmseal - 2 x 27
Published
2026-10-13
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
IFPFormalin, Neutral Buffered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFPFormalin, Neutral BufferedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20849832020343PrimaryGS10
00849832020349Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084983202034320849832020343
00849832020349008498320203498498320203490849832020349

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(800)5374669tech.support@Leicabiosystems.com
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
54
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
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
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
00849832023043Leica Biosystems380085438008542026-10-12
00849832023050Leica Biosystems380085238008522026-10-12
10849832015588Leica Biosystems380173338017332026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849832018619Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832020360Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832022968Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024122Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024153Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024306Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832024368Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
10849832026904Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832020350Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832020695Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832023092Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024105Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024112Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832024396Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
20849832025676Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-13
00849832023036Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-12
00849832023043Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-12
00849832023050Leica BiosystemsLeica Biosystems Richmond, Inc.IFP2026-10-12
00613647018842FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018859FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018866FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018873FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018880FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018897FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027028FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027035FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027042FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028353FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028544FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028575FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30