AccessGUDID - DEVICE: SeroELISA Chlamydia IgG (07290001913147)

GUDID

Device Identifier (DI) Information

Brand Name: SeroELISA Chlamydia IgG
Version or Model: A111-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A111-01
Company Name: SAVYON DIAGNOSTICS LTD

Primary DI Number: 07290001913147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533708202 *Terms of Use

Device Description: The SeroELISA Chlamydia IgG kit is intended for the determination of specific IgG antibody to Chlamydia in a single human serum sample or to evaluate paired sera, by an Enzyme-Linked Immunosorbent Assay (ELISA).

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:	No
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?
50737	Chlamydia pneumoniae immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Chlamydia pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915281	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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 00dd6e47-8247-4160-89fb-a6abb5f5fe6f
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025