AccessGUDID - DEVICE: Axis® Homocysteine EIA (05055845400015)

GUDID

Device Identifier (DI) Information

Brand Name: Axis® Homocysteine EIA
Version or Model: FHCY100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FHCY100
Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED

Primary DI Number: 05055845400015
Issuing Agency: GS1
Commercial Distribution End Date: July 04, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 229062427 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
53751	Homocysteine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of homocysteine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
LPS	Urinary Homocystine (Nonquantitative) Test System
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980907	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b9542d0-ee61-4f74-9296-75043b177572
Public Version Date: May 30, 2025
Public Version Number: 6
DI Record Publish Date: June 13, 2016