3-Reagent Homocysteine Assay for SYNCHRON UniCel FHYB100/B08175

GUDID 05055845400084

The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human ser

AXIS-SHIELD DIAGNOSTICS LIMITED

Homocysteine IVD, reagent
Primary Device ID05055845400084
NIH Device Record Key1bde5089-8078-4b71-ac31-a1fd040ef599
Commercial Distribution StatusIn Commercial Distribution
Brand Name3-Reagent Homocysteine Assay for SYNCHRON UniCel
Version Model NumberFHYB100/B08175
Catalog NumberFHYB100/B08175
Company DUNS229062427
Company NameAXIS-SHIELD DIAGNOSTICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441382422000
EmailMDL-AXD-Product-Support@alere.
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com
Phone+441382422000
EmailMDL-AXD-Product-Support@alere.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105055845400084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPSUrinary Homocystine (Nonquantitative) Test System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-01

Devices Manufactured by AXIS-SHIELD DIAGNOSTICS LIMITED

05055845400527 - Alere NT-proBNP for Alinity Control Kit2025-03-07 The Alere NT-proBNP for Alinity i Controls are for the estimation of test precision and the detection of systematic analytical d
05055845400534 - Alere NT-proBNP for Alinity Calibrator Kit2025-03-07 The Alere NT-proBNP for Alinity i Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative d
05055845400596 - Alere NT-proBNP for Alinity Reagent Kit (200 Tests)2025-03-06 The Alere NT-proBNP for Alinity i assay is a chemiluminescent microparticle immunoassay (CMIA) used for the in vitro quantitativ
05055845400008 - Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptid2018-07-06 The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of
05055845400015 - Axis® Homocysteine EIA2018-07-06 The Axis® Homocysteine Enzyme Immunoassay (EIA) is intended for the quantitative determination of total L-homocysteine in human
05055845400022 - Axis-Shield Homocysteine Controls2018-07-06 The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitati
05055845400046 - Axis-Shield Active-B12 (Holotranscobalamin) EIA2018-07-06 The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holot
05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel2018-07-06The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total homocysteine in human ser
05055845400084 - 3-Reagent Homocysteine Assay for SYNCHRON UniCel2018-07-06 The 3-Reagent Homocysteine Assay for SYNCHRON UniCel DxC System is intended for in vitro quantitative determination of total hom

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.