AccessGUDID - DEVICE: BD GeneOhm™ MRSA ACP Assay (48 tests) (00382904416379)

GUDID

Device Identifier (DI) Information

Brand Name: BD GeneOhm™ MRSA ACP Assay (48 tests)
Version or Model: 441637
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 441637
Company Name: Geneohm Sciences Canada Inc

Primary DI Number: 00382904416379
Issuing Agency: GS1
Commercial Distribution End Date: January 12, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 255438483 *Terms of Use

Device Description: BD GeneOhm™ MRSA ACP Assay (48 tests)

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:	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?
51667	MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQX	SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a181aa3e-1aea-4f26-9c92-ff82cc57f43a
Public Version Date: November 24, 2021
Public Version Number: 4
DI Record Publish Date: August 09, 2016