T-POC TOTAL IgE IMMUNOASSAY KIT

Primary DI
00860009215139
Brand
T-POC TOTAL IgE IMMUNOASSAY KIT
Company
Axim Biotechnologies, Inc.
Model
CP0001
Catalog number
CP0001
Device description
LFIA kit for detection of IgE level in tear fluid.
Published
2024-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009215139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009215139008600092151398600092151390860009215139

GMDN Terms#

Term, Definition table
TermDefinition
Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, rapid ICT, self-testingA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test intended to be used for self-testing by a layperson in the home or similar environment, typically to screen for allergies associated with certain conditions (e.g., food intolerance).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079498248
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009215122Axim Biotechnologies T-POC Lactoferrin Immunoassay KitCP0002CP00022024-03-27
00860009215108VerséaTM Ophthalmics 4.3” Lateral Flow Reader100033000900033000VE2022-10-03
00860009215115VerséaTM Ophthalmics 4.3” Lateral Flow Reader100033000900033000VE2022-10-03