DEVICE: Salmonella Factor H:m serum, 3 mL (05713106403327)

Device Identifier (DI) Information

Salmonella Factor H:m serum, 3 mL
40332
In Commercial Distribution
40332
Ssi Diagnostica A/S
05713106403327
GS1

1
305684449 *Terms of Use
Rabbit antiserum, Ready to use
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
51514 Multiple Salmonella species culture isolate antigen IVD, antibody
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from one or multiple species of Salmonella bacteria isolated by culture from a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GRM Antisera, All Groups, Salmonella 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
No Device Sizes
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Device Record Status

cce059a6-9100-48a4-961d-2f047bf51bfb
July 26, 2021
4
September 13, 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

[?]
+4548299100
info@ssidiagnostica.com
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