FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085023564
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003530C
Device description
Auramine O/Rhodamine B 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
KJKAuramine O

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJKAuramine OHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023571PrimaryGS10
00816085023564Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023571008160850235718160850235710816085023571
00816085023564008160850235648160850235640816085023564

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
00816085021560Alpha-Tec SystemsAlpha-TEC Systems, Inc.KJK2022-08-11
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
30382902125144BD BBL™ TB Auramine MBECTON, DICKINSON AND COMPANYKJK2018-05-25
30382902125151BD BBL™ TB Auramine-Rhodamine TBECTON, DICKINSON AND COMPANYKJK2018-05-25