FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085020549
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003248
Device description
Nocardia Stain Control Slides
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
LJGQuality Control Slides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJGQuality Control SlidesMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085020549PrimaryGS10
00816085020167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085020549008160850205498160850205490816085020549
00816085020167008160850201678160850201670816085020167

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain control IVDA prepared slide(s) and/or other associated material(s) used to verify the performance of a stain or staining kit that is intended to be used for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen.

Regulatory Flags#

DUNS number
103105524
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816085020891Alpha-Tec Systems0X0034572022-08-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B502BSB9016CS0Androgen Receptor Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9017CS0Annexin A1 Control SlidesBIO SB, INC.LJG2025-03-18
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B502BSB9019CS0Arginase-1 Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9020CS0ARID1A Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9021CS0ATM Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9022CS0ATRX Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9023CS0Aurora B Control SlidesBIO SB, INC.LJG2025-03-18
B502BSB9024CS0B7H3/CD276 Control SlidesBIO SB, INC.LJG2025-03-18