FDA.reportPublic FDA data

Lactoferrin ELISA

Primary DI
04050598010406
Brand
Lactoferrin ELISA
Company
Immundiagnostik AG
Model
K 6870.US
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DEGLactoferrin, Antigen, Antiserum, Control

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050598010406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050598010406040505980104064050598010406

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
321663841
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050598163300Albumin ELISAK 63302023-06-21
04050598008540IDK® Pancreatic Elastase ELISAK 6915.20.US2023-06-21
04050598010420IDK® Pancreatic Elastase ELISAK 6915.US2023-06-21
04050598169906Chymotrypsin ActivityK 69902023-06-21
04050598000445Lysozyme ELISAK 69012023-06-21
04050598000452Lysozyme ELISAK 69022023-06-21
04050598000469Lysozyme ELISAK 69032023-06-21
04050598000872α2-Makroglobulin ELISAK 6610A2023-06-21
04050598007673IDK® sIgA ELISAK 8870.20.US2023-06-21
04050598010413Lactoferrin ELISAK 6870.20.US2023-06-21
04050598010437ox-LDL ELISAK 7810.US2023-06-21
04050598010444ox-LDL ELISAK 7810.20.US2023-06-21
04050598010451IDK® sIgA ELISAK 8870.US2023-06-21
04050598010468IDK Extract®K 6999.US2023-06-21
04050598010475Stool preparation system SASK 6998SAS.US2023-06-21
04050598010482Stool preparation system SASK 6998SAS.20.US2023-06-21
04050598010499Retinol-binding protein RBP/RBP4 ELISAK 6110.US2023-06-21
04050598010505Retinol-binding protein RBP/RBP4 ELISAK 6110.20.US2023-06-21
04050598010512IDK Extract®K 6999.17.US2023-06-21
04050598010529IDK Extract®K 6999.20.US2023-06-21

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