AccessGUDID - DEVICE: Axis-Shield Homocysteine Controls (05055845400022)

GUDID

Device Identifier (DI) Information

Brand Name: Axis-Shield Homocysteine Controls
Version or Model: FHCY200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FHCY200
Company Name: AXIS-SHIELD DIAGNOSTICS LIMITED

Primary DI Number: 05055845400022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 229062427 *Terms of Use

Device Description: The Axis-Shield Homocysteine Control Kit is intended to be used as an assayed quality control serum when used for the quantitative measurement of total L-homocysteine in human serum or plasma.

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:	No
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?
53750	Homocysteine IVD, control	A material which is used to verify the performance of an assay intended to be 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)
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: 4f971af8-835d-4596-b55a-faba4cd1e822
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: July 01, 2016