FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085023588
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103105524
Device count
8
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
false
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
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
00816085023595Alpha-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
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