FDA.reportPublic FDA data

CRYPTOSPORIDIUM II

Primary DI
00857031002301
Brand
CRYPTOSPORIDIUM II
Company
TECHLAB, INC.
Model
PT5014
Device description
The CRYPTOSPORIDIUM II test is an enzyme immunoassay for the qualitative detection of Cryptosporidium oocyst antigen in human fecal specimens. It is indicated for use as an aid in the diagnosis of patients with diarrhea suspected of Cryptosporidium gastrointestinal infection.
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MHJCryptosporidium Spp.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHJCryptosporidium Spp.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052932000CRYPTOSPORIDIUM IITechlab, Inc.2005-11-04MHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002301008570310023018570310023010857031002301

GMDN Terms#

Term, Definition table
TermDefinition
Cryptosporidium species 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 antigens from species of the parasitic protozoan Cryptosporidium in a clinical specimen, using an enzyme immunoassay (EIA) method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857031002547TRI-COMBO PARASITE SCREENT50322019-05-31
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
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
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-09-01
04048474034677Cryptosporidium Antigen (stool) ELISA DRG Instruments Gesellschaft mit beschränkter HaftungMHJ2023-08-29
00840239034670Cryptosporidium Antigen (stool) ELISA DRG International IncMHJ2023-08-24
00083059070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2020-07-01
00857031002547TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2019-05-31
00857031002400TRI-COMBO PARASITE SCREENTECHLAB, INC.MHJ2017-10-05
08305900070637Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay]BIOMERICA, INC.MHJ2016-12-08
00848838026898NAREMEL, INC.MHJ2016-09-24
00848838026904NAREMEL, INC.MHJ2016-09-24
00848838026935NAOXOID LIMITEDMHJ2016-09-24
00893038002180Triage®Alere San Diego, Inc.MHJ2016-09-21
M445MCCCGDFA750Para-Tect Cryptosporidium/Giardia Direct Fluorescence AssayMEDICAL CHEMICAL CORPORATIONMHJ2016-09-20
05391516746342TrinityBiotechMARDX DIAGNOSTICS, INC.MHJ2016-09-18
05391516746359Trinity BiotechMARDX DIAGNOSTICS, INC.MHJ2016-09-18
00857031002035CRYPTOSPORIDIUM IITECHLAB, INC.MHJ2016-08-23
00857031002127GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23
00857031002240GIARDIA/CRYPTOSPORIDIUM CHEKTECHLAB, INC.MHJ2016-08-23