Alpha-Tec Systems

Primary DI
00816085023656
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
0004060
Device description
PARA-PRO fc50
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
LKSDevice, Parasite Concentration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKSDevice, Parasite ConcentrationMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053257000PARA-PRO FC50Alpha-Tec Systems, Inc.2006-05-12LKS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816085023656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085023656008160850236568160850236560816085023656

GMDN Terms#

Term, Definition table
TermDefinition
Faecal parasite specimen concentration kit IVDA collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
103105524
Device count
1
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
00810044208146Caplugs/EvergreenCAPlugsLKS2024-05-31
00810044208153Caplugs/EvergreenCAPlugsLKS2024-05-31
00810044208160Caplugs/EvergreenCAPlugsLKS2024-05-31
00810044208177Caplugs/EvergreenCAPlugsLKS2024-05-31
00840733103445Para-Pak CON-TrateMERIDIAN BIOSCIENCE, INC.LKS2021-10-27
00840733102684CON-Trate Funnels & Reagent A MERIDIAN BIOSCIENCE, INC.LKS2020-12-10
00840733102424SpinCon MERIDIAN BIOSCIENCE, INC.LKS2020-12-09
00840733102639Para-Pak SpinCon (No Funnels)MERIDIAN BIOSCIENCE, INC.LKS2020-12-09
00840733102646Para-Pak CON-TrateMERIDIAN BIOSCIENCE, INC.LKS2020-12-09
00840733102653Reagent A (230mL)MERIDIAN BIOSCIENCE, INC.LKS2020-12-09
00840733102028Para-Pak Macro-CONMERIDIAN BIOSCIENCE, INC.LKS2020-10-26
00840733102059FeKal CON-TrateĀ® Reagent BMERIDIAN BIOSCIENCE, INC.LKS2020-10-26
00840733102394SpinConMERIDIAN BIOSCIENCE, INC.LKS2020-10-26
00840733102561Para-Pak CON-TrateMERIDIAN BIOSCIENCE, INC.LKS2020-10-06
00840733102721Para-Pak CON-TrateMERIDIAN BIOSCIENCE, INC.LKS2020-10-06
00840733102592CON-Trate Bulk Tubes & CapsMERIDIAN BIOSCIENCE, INC.LKS2020-09-21
50885380144934CARDINAL HEALTHCardinal Health 200, LLCLKS2019-06-28
M445693A50PACK1SED-CONNECTMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445693AESEDEA50PACK1SED-CONNECTMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445693AFUNNEL1SED-CONNECTMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445693ASAMPLE1SED-CONNECTMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445694A1MICRO-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445694AEA1MICRO-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445694ASAMPLE1MICRO-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445694ATUBEFUNNEL1MICRO-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445695A1PARA-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445695AEA1PARA-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20
M445695ASAMPLE1PARA-SEDMEDICAL CHEMICAL CORPORATIONLKS2016-09-20