LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip

Primary DI
06972164410039
Brand
LOOKEE® AscleTrack™ Heart-type Fatty Acid-Binding Protein (H-FABP) Test Strip
Company
Kunming Lianen Biotechnology Co., LTD
Model
A801
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JLHTitrimetric, Fatty Acids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JLHTitrimetric, Fatty AcidsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972164410039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972164410039069721644100396972164410039

GMDN Terms#

Term, Definition table
TermDefinition
Non-esterified fatty acid IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of non-esterified fatty acid in a clinical specimen.

Regulatory Flags#

DUNS number
407581068
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972164410008LOOKEE® AscleTrack™ Urine Test AnalyzerA802026-06-26
06972164410015Semi-Quantitative Follicle-Stimulating Hormone (FSH) Test Strip/2026-06-26
06972164410022LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test StripA8022026-06-26

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Primary DI, Brand, Company table
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04987481164604HR Series NEFA-HR(2) Color Reagent AFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01
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04987481164635HR Series NEFA-HR(2) Solvent BFUJIFILM WAKO PURE CHEMICAL CORPORATIONJLH2021-06-01