DEVICE: BD MAX™ MRSA XT (00382904434618)

Device Identifier (DI) Information

BD MAX™ MRSA XT
443461
In Commercial Distribution
443461
Geneohm Sciences Canada Inc
00382904434618
GS1

1
255438483 *Terms of Use
BD MAX™ MRSA XT 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
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Device Characteristics

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

GMDN

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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).
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FDA Product Code

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Product Code Product Code Name
NQX SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN
OOI real time Nucleic acid amplification system
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133605 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

36749d0b-7509-4014-b909-273c192f6101
July 06, 2018
3
April 12, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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