FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085022703
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Device description
10% Formalin, Buffered bag kit
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
IFPFormalin, Neutral Buffered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFPFormalin, Neutral BufferedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085022703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085022703008160850227038160850227030816085022703

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.

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
Contains natural rubber latex
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
00613647018842FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018859FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018866FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018873FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018880FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018897FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027028FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027035FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027042FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028353FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028544FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028575FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028599FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018846FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018853FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018860FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018877FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018884FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018891FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027022FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027039FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027046FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647028357FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028360FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028377FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028384FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028391FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028407FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647028548FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028551FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30