AccessGUDID - DEVICE: ELISA M. pneumoniae Q IgG Test System (00845533000918)

GUDID

Device Identifier (DI) Information

Brand Name: ELISA M. pneumoniae Q IgG Test System
Version or Model: Q3Z17601GB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Q3Z17601GB
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533000918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS ELISA Mycoplasma pneumoniae IgG Test System provides a means for the qualitative detection of IgG antibodies to Mycoplasma pneumoniae in human sera. The test may aid in the determination of the patient’s serological status, or may aid in the diagnosis of disease associated with Mycoplasma pneumoniae. Potential cross-reactivity with M. genitalium has not been assessed, nor were studies performed on very young and/or elderly patients.

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?
51207	Mycoplasma 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 Mycoplasma pneumoniae bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 238caecf-81c7-4f1c-afb5-ca22dacc50c6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016