FDA.reportPublic FDA data

LEUKO EZ VUE

Primary DI
00857031002172
Brand
LEUKO EZ VUE
Company
TECHLAB, INC.
Model
T30355
Device description
The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing.
Published
2019-04-12
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
DEGLactoferrin, Antigen, Antiserum, Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DEGLactoferrin, Antigen, Antiserum, ControlImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071712000LEUKO EZ VUETechlab Inc., Corporate Research Center2007-12-04DEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002172008570310021728570310021720857031002172

GMDN Terms#

Term, Definition table
TermDefinition
Lactoferrin IVD, kit, immunochromatographic test (ICT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of lactoferrin in a clinical specimen, using an immunochromatographic test (ICT) 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
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
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
B24280LACHUFC9000ALPCO Lactoferrin CLIA KitAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DEG2026-03-31
08437029987012GeroaDXGEROA DIAGNOSTICS SOCIEDAD LIMITADA.DEG2025-12-10
B24280LACHUFCSET0Lactoferrin CLIA Re-Calibrator and Control SetAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DEG2025-06-06
B24280LACHUFC1000ALPCO Lactoferrin CLIA KitAMERICAN LABORATORY PRODUCTS COMPANY, LTD.DEG2025-03-03
04048474036022Anti-Lactoferrin ELISADRG Instruments Gesellschaft mit beschränkter HaftungDEG2023-08-29
04050598010406Lactoferrin ELISAImmundiagnostik AGDEG2023-06-21
04050598010413Lactoferrin ELISAImmundiagnostik AGDEG2023-06-21
00404847436020Anti-Lactoferrin ELISADRG Instruments Gesellschaft mit beschränkter HaftungDEG2021-07-28
00857031002530LEUKO EZ VUETECHLAB, INC.DEG2020-01-24
00857031002356LACTOFERRIN EZ VUETECHLAB, INC.DEG2019-05-31
00857031002585QuickVue TLI Lactoferrin TestTECHLAB, INC.DEG2019-05-30
00857031002080LACTOFERRIN CHEKTECHLAB, INC.DEG2019-05-29
00857031002189LACTOFERRIN EZ VUETECHLAB, INC.DEG2019-05-29
00857031002097LACTOFERRIN SCANTECHLAB, INC.DEG2019-04-12
00857031002271LACTOFERRIN CHEKTECHLAB, INC.DEG2019-04-12
00857031002288LACTOFERRIN SCANTECHLAB, INC.DEG2019-04-12