FDA.reportPublic FDA data

TRI-COMBO PARASITE SCREEN

Primary DI
00857031002547
Brand
TRI-COMBO PARASITE SCREEN
Company
TECHLAB, INC.
Model
T5032
Device description
The TECHLAB® TRl-COMBO PARASITE SCREEN test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp. and/or E. histolytica antigen in human fecal specimens. The test is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. The test does not differentiate between the three parasites and follow-up testing is required for all positive results to confirm the specific diagnosis.
Published
2019-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
MHIGiardia Spp.
MHJCryptosporidium Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHWAntigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.Microbiology2
MHIGiardia Spp.Microbiology2
MHJCryptosporidium Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171078000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171078000TRI-COMBO PARASITE SCREENTechlab, Inc.2017-07-10MHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002547008570310025478570310025470857031002547

GMDN Terms#

Term, Definition table
TermDefinition
Multiple faecal parasite antigen IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple faecal parasite antigens (e.g., Giardia, Entamoeba and Cryptosporidium species) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614218634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002554C. DIFF QUIK CHEK COMPLETET50382019-05-31
00857031002073C. DIFFICILE TOX-B TEST30399U2020-01-24
00857031002530LEUKO EZ VUET50192020-01-24
00857031002561QuickVue TLI H. pylori Test203432019-05-30
00857031002226C. DIFF CHEK - 60T50252019-04-12
00857031002455CAMPYLOBACTER QUIK CHEKT50472019-04-12
00857031002301CRYPTOSPORIDIUM IIPT50142016-08-23
00857031002523H. PYLORI CHEK309962018-09-28
00857031002356LACTOFERRIN EZ VUET50182019-05-31
00857031002585QuickVue TLI Lactoferrin Test203452019-05-30
00857031002189LACTOFERRIN EZ VUE303532019-05-29
00857031002172LEUKO EZ VUET303552019-04-12
00857031002646C. DIFFICILE TOX A/B IIT5015XB2021-05-07
00857031002660C. DIFF CHEK - 60TL50252021-05-03
00857031002639H. PYLORI CHEK T5051B2021-03-12
00857031002066C. DIFFICILE TOXIN ANTITOXIN KITT50002020-01-24
00857031002264C. DIFFICILE TOX-B TESTT50032020-01-24
00857031002622QuickVue TLI H. pylori Stool Antigen Test203432019-09-26
00857031002196SHIGA TOXIN QUIK CHEKT306252019-08-06
00857031002417SHIGA TOXIN CHEKT306962019-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115934298T-Handle with Pendulum AdaptorPREMIA SPINE LTDMHI2024-09-03
ENTIENTG01400NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
ENTIENTG0140NovaLisa Entamoeba histolytica IgGGold Standard Diagnostics Frankfurt GmbHKHW2024-08-26
00894175000282AccuDiag ™Diagnostic Automation, Inc.KHW2024-03-06
0404847405955721-Hydroxylase Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-09-01
04048474038309Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-31
04048474034677Cryptosporidium Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-08-29
04048474034745Entamoeba histolytica IgG ELISADRG Instruments Gesellschaft mit beschränkter HaftungKHW2023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHI2023-08-29
00840239060594Giardia/Cryptosporidium Ag (stool) ELISA DRG International IncMHI2023-08-26
00840239038302Entamoeba histolytica IgG ELISADRG International IncKHW2023-08-25
00840239034670Cryptosporidium Antigen (stool) ELISA DRG International IncMHJ2023-08-24
00840239034779Giardia lamblia Antigen (stool) ELISA DRG International IncMHI2023-08-24
00848838026683ProSpecTREMEL, INC.MHI2022-12-23
B350GSD0130130Entamoeba histolytica IgG ELISA Test KitGold Standard Diagnostics CorporationKHW2022-11-18
07640158219652Fasciola hepatica IgG ELISA Bordier affinity products S.A.KHW2022-09-30
07640158219553Entamoeba histolytica IgG ELISA Bordier affinity products S.A.KHW2022-08-09
00083059070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2020-07-01
00083059070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2020-07-01
00083059070781E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.KHW2020-07-01
00083059150155EZ-GIARDIA One-Step Giardia TestBIOMERICA, INC.MHI2020-07-01
00840239034748E. Histolytica IgG ELISADRG International IncKHW2019-03-20
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHI2017-10-05
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.KHW2017-10-05
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2017-10-05
00857031002202E. HISTOLYTICA QUIK CHEKTECHLAB, INC.KHW2017-09-15
00742860100017ImmunoStat G/C 30 Test KitSEKISUI DIAGNOSTICS, LLCMHI2017-01-10
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2016-12-08
08305900070699Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHI2016-12-08