DEVICE: BD MAX™ Enteric Bacterial Panel (US/CAN) (00382904433789)

Device Identifier (DI) Information

BD MAX™ Enteric Bacterial Panel (US/CAN)
443378
In Commercial Distribution
443378
Geneohm Sciences Canada Inc
00382904433789
GS1

1
255438483 *Terms of Use
BD MAX™ Enteric Bacterial Panel (US/CAN)
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Multiple gastrointestinal disease-associated bacteria 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 one or more bacteria associated with gastrointestinal diseases, in a clinical specimen, using a nucleic acid technique (NAT). Bacteria detected may include Salmonella, Shigella, Campylobacter, Escherichia coli (E. coli), Bacillus and/or Vibrio species.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PCH Gastrointestinal pathogen panel multiplex nucleic acid-based assay system
PCI Gastrointestinal bacterial panel multiplex nucleic acid-based assay system
OOI real time Nucleic acid amplification system
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140111 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

d419b0ef-de37-40ba-86ce-f324d7f7dad3
July 06, 2018
3
July 27, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)638-8663
Technical_services@bd.com
CLOSE