FDA.reportPublic FDA data

Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent

Primary DI
05055845400282
Brand
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent
Company
AXIS-SHIELD DIAGNOSTICS LIMITED
Model
FHBC100/B08176
Catalog number
FHBC100/B08176
Device description
The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Published
2016-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JITCalibrator, Secondary
LPSUrinary Homocystine (Nonquantitative) Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2
LPSUrinary Homocystine (Nonquantitative) Test SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083222000AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100Axis-Shield Diagnostics, Ltd.2009-07-31LPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055845400282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055845400282050558454002825055845400282

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
+441382422000MDL-AXD-Product-Support@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
05055845400015Axis® Homocysteine EIAFHCY100FHCY1002016-06-13
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
05055845400527Alere NT-proBNP for Alinity Control Kit04S791104S79112025-02-27
05055845400534Alere NT-proBNP for Alinity Calibrator Kit04S790204S79022025-02-27

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