FDA.reportPublic FDA data

REMEL

Primary DI
00848838024054
Brand
REMEL
Company
REMEL, INC.
Model
R21641
Catalog number
R21641
Device description
Formalin 10% (15ml) PK/288
Published
2022-12-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00848838024054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848838024054008488380240548488380240540848838024054

GMDN Terms#

Term, Definition table
TermDefinition
Neutral buffered formalin IVDA neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065769564
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848838065361ImmunoDOT Autoimmunity Panel 1 KT/100TSTR24709402026-07-20
00848838018855NACP114-102016-09-24
00848838031274REMELR40041R400412023-01-03
00842558116709Spectra™ Candida Agar R018332026-02-09
00848838072772MicroTest M6R12582R125822022-12-22
00848838074844MicroTest M4RTR12567R125672022-12-22
00848838075018MicroTest M6R12560R125602022-12-22
00848838091827NA7115-602022-04-21
00848838091742VersaTREK™ VersaTREK™ Myco Streptomycin, 7120-302025-01-16
00848838091834NA7116-702016-12-09
00848838003158Strep Selective II AgarR018592026-01-16
00848838059865^BM^ PK/50 OXIDASE TESTR90556352026-01-16
00848838066856Liquid Amies,Dual Swab PK/50R7230952025-06-18
00848838066887Liquid Stuarts,Single Swab PK/500R7231102025-06-18
00848838066894Liquid Stuarts,Single Swab PK/50R7231152025-06-18
00848838066900Liquid Stuarts,Dual Swab PK/500R7231202025-06-18
00848838066917Liquid Stuarts,Dual Swab PK/50R7231252025-06-18
00848838066924Liquid Stuarts,Wire Shaft Swab PK/100R7231302025-06-18
00848838066931Liquid Stuarts,Wire Shaft PK/50R7231352025-06-18
00848838011177Sensititre Demineralized WaterT33392023-12-21

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
20849832020343Leica 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