AccessGUDID - DEVICE: MERIFLUOR Pneumocystis (00840733101106)

GUDID

Device Identifier (DI) Information

Brand Name: MERIFLUOR Pneumocystis
Version or Model: 222030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 222030
Company Name: MERIDIAN BIOSCIENCE, INC.

Primary DI Number: 00840733101106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092815364 *Terms of Use

Device Description: MERIFLUOR Pneumocystis is an in vitro direct immunofluorescent detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens.

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?
52096	Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from the fungus Pneumocystis jirovecii (formerly known as P. carinii) in a clinical specimen, using a direct fluorescent test (DFT).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYF	Pneumocystis Carinii

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
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: 4e952ab4-4ef9-477f-b6ec-d3d374297d9d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016