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

Device Identifier (DI) Information

BD GeneOhm™ MRSA ACP Assay (48 tests)
441637
In Commercial Distribution
441637
Geneohm Sciences Canada Inc
00382904416379
GS1

1
255438483 *Terms of Use
BD GeneOhm™ MRSA ACP Assay (48 tests)
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
MRSA nucleic acid detection IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen, using a nucleic acid technique (NAT).
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

a181aa3e-1aea-4f26-9c92-ff82cc57f43a
March 29, 2018
2
August 09, 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