DEVICE: BD Difco™ QC Antigen Alkalescens Dispar Group 1 (00382902211617)

Device Identifier (DI) Information

BD Difco™ QC Antigen Alkalescens Dispar Group 1
221161
In Commercial Distribution
221161
BECTON, DICKINSON AND COMPANY
00382902211617
GS1

1
122561087 *Terms of Use
BD Difco™ QC Antigen Alkalescens Dispar Group 1
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
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
Escherichia coli Alkalescens-Dispar antigen IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from Escherichia coli Alkalescens-Dispar bacteria in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
LIA ANTIGENS, ALL GROUPS, SHIGELLA SPP.
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FDA Premarket Submission

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

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 1 Milliliter
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Device Record Status

1b3f372f-87f7-4c0d-9ad9-8a5ec487d2fa
March 29, 2018
2
April 28, 2016
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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
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Secondary DI

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

[?]
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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