FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085021461
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Device description
PROTO-FIX [2 Vials] /Clean Vial bag kit
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
LDZFixative, Alcohol Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDZFixative, Alcohol ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085021355PrimaryGS10
00816085021461Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085021355008160850213558160850213550816085021355
00816085021461008160850214618160850214610816085021461

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

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
00673693181723EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-11-19
00673693228299EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-09-04
00673693085465EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693556729EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00673693755146EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLDZ2024-07-24
00860011780571Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00860011780588Chemical Service Labs, LLCProtean Resources, LLC.LDZ2024-03-18
00380740129590AlinityAbbott GmbHLDZ2023-11-16
M84941010Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
M84941012Hobbs Medical Saccomanno Cell Transport SystemHOBBS MEDICAL, INC.LDZ2023-06-12
00810047420545N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420552N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420569N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420934N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420941N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420958N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00810047420965N/AScientific Device Laboratory, Inc.LDZ2023-01-31
00816085021393Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021409Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021478Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022376Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022444Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022468Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022499Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085022512Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085020181Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021423Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021430Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021447Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11
00816085021454Alpha-Tec SystemsAlpha-TEC Systems, Inc.LDZ2022-08-11