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.
00863840000254
GS1

1
622988330 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OYV Inherited Nucleotide Repeat Disorder Dna Test
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN190023 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between -30 and -15 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

04a6fb18-5ac0-4b00-bdd8-770addffa1dd
April 15, 2020
1
April 07, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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