AccessGUDID - DEVICE: BD MAX™ Enteric Parasite Panel (US/CAN) (00382904433802)

GUDID

Device Identifier (DI) Information

Brand Name: BD MAX™ Enteric Parasite Panel (US/CAN)
Version or Model: 443380
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 443380
Company Name: Geneohm Sciences Canada Inc

Primary DI Number: 00382904433802
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 255438483 *Terms of Use

Device Description: BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer

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?
61058	Multiple-type gastrointestinal pathogen 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 from multiple types of microorganisms associated with gastrointestinal disease, in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include bacteria, viruses, fungi and/or parasites such as, but are not limited to Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Norovirus, Rotavirus, Clostridium difficile, Giardia, Bacillus and/or Vibrio species.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCH	Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
OOI	real time Nucleic acid amplification system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143648	000

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: 8e1e2c71-c924-4681-a9b3-b949c7f18c1f
Public Version Date: June 09, 2022
Public Version Number: 5
DI Record Publish Date: May 19, 2016