DEVICE: Simplexa™ Group A Strep Positive Control Pack (20816101025576)

Device Identifier (DI) Information

Simplexa™ Group A Strep Positive Control Pack
MOL2860
In Commercial Distribution
MOL2860
DIASORIN MOLECULAR LLC
20816101025576
GS1

1
080271715 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
51716 Beta-haemolytic Group A Streptococcus nucleic acid 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 nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K143651 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between -30 and -10 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

96d6dc4e-16f5-42d3-9ce0-12e782b05bfd
July 08, 2024
4
September 22, 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

[?]
562-240-6500
TS.Molecular@DiaSorin.com
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