BD MAX™ Enteric Parasite Panel (US/CAN)

Basic Information

• Brand Name: BD MAX™ Enteric Parasite Panel (US/CAN)
• Primary DI: 00382904433802
• Version / Model: 443380
• Catalog Number: 443380
• Company Name: Geneohm Sciences Canada Inc
• Labeler DUNS: 255438483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 5
• Public Version Date: 2022-06-09
• Public Version Status: Update
• Public Device Record Key: 8e1e2c71-c924-4681-a9b3-b949c7f18c1f
• Distribution End Date: 2018-01-16

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PCH	Gastrointestinal pathogen panel multiplex nucleic acid-based assay system	Microbiology	866.3990	2
OOI	real time Nucleic acid amplification system	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904433802	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143648	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius