FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085021560
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003570
Device description
Rapid Auramine O Stain Set
Published
2022-08-11
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
KJKAuramine O

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJKAuramine OHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085021560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085021560008160850215608160850215600816085021560

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
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
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
00816085021577Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021638Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021645Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085021652Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
00816085023519Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023571Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085020778Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085020808Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023502Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
00816085023564Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-08
30382902125144BD BBL™ TB Auramine MBECTON, DICKINSON AND COMPANYKJK2018-05-25
30382902125151BD BBL™ TB Auramine-Rhodamine TBECTON, DICKINSON AND COMPANYKJK2018-05-25