FDA.reportPublic FDA data

Axis® Homocysteine EIA

Primary DI
05055845400015
Brand
Axis® Homocysteine EIA
Company
AXIS-SHIELD DIAGNOSTICS LIMITED
Model
FHCY100
Catalog number
FHCY100
Device description
The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Published
2016-06-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
LPSUrinary Homocystine (Nonquantitative) Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DFCLipoprotein, Low-Density, Antigen, Antiserum, ControlImmunology2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
LPSUrinary Homocystine (Nonquantitative) Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980907000AXIS HOMOCYSTEINE ENZYME IMMUNOASSAYAxis Biochemicals, Asa1998-10-16LPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055845400015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055845400015050558454000155055845400015

GMDN Terms#

Term, Definition table
TermDefinition
Homocysteine 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 homocysteine in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441382422000MDL-AXD-Product-Support@alere.
+441382422000MDL-AXD-Product-Support@alere.com
+1-877-441-7440USproductsupport@abbott.com

Regulatory Flags#

DUNS number
229062427
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
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)04S792104S79212025-02-26
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002019-08-02
05055845400008Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002016-09-01
05055845400022Axis-Shield Homocysteine ControlsFHCY200FHCY2002016-07-01
05055845400046Axis-Shield Active-B12 (Holotranscobalamin) EIAFMABT100FMABT1002016-09-02
050558454000843-Reagent Homocysteine Assay for SYNCHRON UniCelFHYB100/B08175FHYB100/B081752016-07-01
05055845400169Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR100FHRWR1002016-07-01
05055845400176Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR200FHRWR2002016-07-01
05055845400183Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR1000FHRWR10002016-07-01
05055845400282Axis-Shield Liquid Stable (LS) 2-Part Homocysteine ReagentFHBC100/B08176FHBC100/B081762016-07-01
05055845400527Alere NT-proBNP for Alinity Control Kit04S791104S79112025-02-27
05055845400534Alere NT-proBNP for Alinity Calibrator Kit04S790204S79022025-02-27

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