AccessGUDID - DEVICE: Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit (B3507202800)

GUDID

Device Identifier (DI) Information

Brand Name: Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit
Version or Model: 720-280
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720-280
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B3507202800
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease.

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?
55126	Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to scleroderma-70 (anti-Scl-70) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLL	Extractable Antinuclear Antibody, Antigen And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 57c39795-8041-479a-8253-d142b5bb5dbf
Public Version Date: June 04, 2021
Public Version Number: 2
DI Record Publish Date: July 27, 2020