FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085022154
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0003712
Device description
816085022260
Published
2022-08-10
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
IGBSolution, Formalin-Sodium Acetate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IGBSolution, Formalin-Sodium AcetatePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085022154PrimaryGS10
00816085022260Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085022154008160850221548160850221540816085022154
00816085022260008160850222608160850222600816085022260

GMDN Terms#

Term, Definition table
TermDefinition
Faecal specimen collection kit IVD, home-useA collection of devices and materials intended to be used by a layperson in the home to self-collect a faecal (stool) sample for subsequent in vitro diagnostic testing or screening purposes (e.g., occult blood, cytology) in a clinical laboratory. The kit may consist of a specimen container(s) with or without an additive/medium (e.g., cell or nucleic acid preservative solution, Carey-Blair transport medium), collection assistive device(s) (e.g., blush, spatula), gloves, labels, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.

Regulatory Flags#

DUNS number
103105524
Device count
32
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
00848838024214REMELREMEL, INC.IGB2022-12-23
00848838024221REMELREMEL, INC.IGB2022-12-23
00848838024375REMELREMEL, INC.IGB2022-12-23
00816085022260Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-11
00816085022550Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022666Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
00816085022833Alpha-Tec SystemsAlpha-TEC Systems, Inc.IGB2022-08-10
M445891051O&P Collection Vials SAF / Clean/ C&S KitsMEDICAL CHEMICAL CORPORATIONIGB2020-08-31
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection KitMEDICAL CHEMICAL CORPORATIONIGB2020-08-31
M445891050O&P Collection Vials SAF / Clean/ C&S KitsMEDICAL CHEMICAL CORPORATIONIGB2020-08-31