DEVICE: BD Difco™ QC Antigen Shigella Group A (00382902210016)

Device Identifier (DI) Information

BD Difco™ QC Antigen Shigella Group A
221001
In Commercial Distribution
221001
BECTON, DICKINSON AND COMPANY
00382902210016
GS1

1
122561087 *Terms of Use
BD Difco™ QC Antigen Shigella Group A
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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
Multiple Shigella species culture isolate antigen IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative detection of antigens from one or multiple species of Shigella bacteria isolated by culture from 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

eb809b80-1c40-43db-b531-1a5b37e64978
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

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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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