FDA.reportPublic FDA data

LACTOFERRIN CHEK

Primary DI
00857031002080
Brand
LACTOFERRIN CHEK
Company
TECHLAB, INC.
Model
30352
Device description
The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active irritable bowel syndrome (IBS), which is noninflammatory.
Published
2019-05-29
Public version status
New
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
K011396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011396000IBD-CHEKTechlab, Inc.2001-06-18DEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857031002080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857031002080008570310020808570310020800857031002080

GMDN Terms#

Term, Definition table
TermDefinition
Lactoferrin 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 lactoferrin 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
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

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
00857031002189LACTOFERRIN EZ VUETECHLAB, INC.DEG2019-05-29
00857031002097LACTOFERRIN SCANTECHLAB, INC.DEG2019-04-12
00857031002172LEUKO EZ VUETECHLAB, INC.DEG2019-04-12
00857031002271LACTOFERRIN CHEKTECHLAB, INC.DEG2019-04-12
00857031002288LACTOFERRIN SCANTECHLAB, INC.DEG2019-04-12