AccessGUDID - DEVICE: Mycoplasma pneumoniae Negative Control (B110MPN12100)

GUDID

Device Identifier (DI) Information

Brand Name: Mycoplasma pneumoniae Negative Control
Version or Model: MPN-1210
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPN-1210
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110MPN12100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024824641 *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:	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?
51205	Mycoplasma pneumoniae immunoglobulin M (IgM) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen.	Active	false
51210	Mycoplasma pneumoniae immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Mycoplasma pneumoniae bacteria in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQG	Dna-Reagents, 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: 60590a0f-ba89-4108-89e6-8402f566c1a1
Public Version Date: March 04, 2020
Public Version Number: 3
DI Record Publish Date: September 12, 2016