DEVICE: AmplideX Fragile X Dx & Carrier Screen Kit (00863840000254)
Device Identifier (DI) Information
AmplideX Fragile X Dx & Carrier Screen Kit
49591
In Commercial Distribution
49591
ASURAGEN, INC.
49591
In Commercial Distribution
49591
ASURAGEN, INC.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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59480 | Fragile X syndrome IVD, kit, nucleic acid technique (NAT) |
A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Fragile X syndrome, using a nucleic acid technique (NAT). The disorder results in mild to moderate mental retardation and is associated with trinucleotide repeat expansion or deletion of the CCG triplet in the FMR1 and/or FMR2 genes located on the X chromosome.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OYV | Inherited Nucleotide Repeat Disorder Dna Test |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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DEN190023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -30 and -15 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
04a6fb18-5ac0-4b00-bdd8-770addffa1dd
April 15, 2020
1
April 07, 2020
April 15, 2020
1
April 07, 2020
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
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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