FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085022000
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003536C
Device description
Thiazine Red Counterstain 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
JTSStains, Microbiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K881042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K881042000ATS TRICHROME STAIN (WHEATLEY'S MODIFICATION)Alpha-Tec Systems, Inc.1988-03-30JTS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085022000PrimaryGS10
00816085021997Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085022000008160850220008160850220000816085022000
00816085021997008160850219978160850219970816085021997

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
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
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00673693089258EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693169011EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693236461EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-09-05
00673693168984EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-09
00673693168991EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
00673693169080EprediaRICHARD-ALLAN SCIENTIFIC COMPANYJTS2024-08-07
00810047422068N/AScientific Device Laboratory, Inc.JTS2024-07-11
30382902125250BD BBL™ Gram Crystal VioletBECTON, DICKINSON AND COMPANYJTS2023-09-19
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00810047420712N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420729N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420736N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420743N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420750N/AScientific Device Laboratory, Inc.JTS2023-01-31
00810047420781N/AScientific Device Laboratory, Inc.JTS2023-01-31