FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085023595
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003531C
Device description
Ziehl-Neelsen Carbolfushsin Stain 8x250ml
Published
2022-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ICLCarbol Fuchsin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ICLCarbol FuchsinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023595PrimaryGS10
00816085023588Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023595008160850235958160850235950816085023595
00816085023588008160850235888160850235880816085023588

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
103105524
Device count
8
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816085020549Alpha-Tec Systems000032482022-08-11
00816085020921Alpha-Tec Systems000043022022-08-11
00816085020938Alpha-Tec Systems000043032022-08-11
00816085020945Alpha-Tec Systems000043042022-08-11
00816085020952Alpha-Tec Systems000043052022-08-11
00816085020969Alpha-Tec Systems000043062022-08-11
00816085020976Alpha-Tec Systems000043072022-08-11
00816085020983Alpha-Tec Systems000043082022-08-11
00816085020990Alpha-Tec Systems000043092022-08-11
00816085023069Alpha-Tec Systems000034532022-08-11
00816085023670Alpha-Tec Systems000033712022-08-11
00816085024073Alpha-Tec Systems000048132022-08-11
00816085020075Alpha-Tec Systems0S0032222022-08-11
00816085020105Alpha-Tec Systems0S0032232022-08-11
00816085020273Alpha-Tec Systems02022-08-11
00816085020334Alpha-Tec Systems0S0032242022-08-11
00816085020167Alpha-Tec Systems00003248S2022-08-11
00816085020655Alpha-Tec Systems000033592022-08-11
00816085020877Alpha-Tec Systems0X0000202022-08-11
00816085020884Alpha-Tec Systems0X0034412022-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693089265EprediaRICHARD-ALLAN SCIENTIFIC COMPANYICL2024-08-07
00848838065767REMELREMEL, INC.ICL2022-12-23
00848838065958REMELREMEL, INC.ICL2022-12-23
00816085022086Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-10
00816085023458Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020822Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085020853Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023441Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
00816085023588Alpha-Tec SystemsAlpha-TEC Systems, Inc.ICL2022-08-08
04015630971732AFB III Staining KitVentana Medical Systems, Inc.ICL2021-02-08
07613336157510BenchMark Special Stains AFB Staining KitVentana Medical Systems, Inc.ICL2021-02-08
SO359852042008Rowley Biochemical Kinyoun's Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO471852042008Rowley Biochemical Ziehl-Neelsen Carbol Fuchsin SolutionTRANSENE COMPANY, INC.ICL2019-09-16
SO490852042008Rowley Biochemical Carbol FuchsinTRANSENE COMPANY, INC.ICL2019-09-16
30382902125113BD BBL™ TB Carbolfuchsin ZNBECTON, DICKINSON AND COMPANYICL2018-05-25
30382902125182BD BBL™ TB Carbolfuchsin KFBECTON, DICKINSON AND COMPANYICL2018-05-25