DEVICE: Alere™ i Strep A Control Swab Kit (10811877010866)
Device Identifier (DI) Information
Alere™ i Strep A Control Swab Kit
733-080
Not in Commercial Distribution
Alere Scarborough, Inc.
733-080
Not in Commercial Distribution
Alere Scarborough, Inc.
Control Swabs intended for use only with the Alere i Strep A product.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System |
OOI | Real Time Nucleic Acid Amplification System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0bd9345b-ba34-4fd8-b4ae-6826409a8a3c
September 12, 2023
3
September 03, 2016
September 12, 2023
3
September 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined