AccessGUDID - DEVICE: Anti-Mycoplasma pneumoniae IFA (IgM) (04049016055198)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Mycoplasma pneumoniae IFA (IgM)
Version or Model: FI 2202-1005 M
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016055198
Issuing Agency: GS1
Commercial Distribution End Date: September 11, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 322209263 *Terms of Use

Device Description: No description.

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):	No
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?
51203	Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GRZ	Antisera, Fluorescent, All, Mycoplasma Spp.

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 55182f80-c456-4b25-8546-8eae3c29340e
Public Version Date: September 14, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016