DEVICE: Fragile X Fluorescein-Labelled Probe (05700571112526)

Device Identifier (DI) Information

Fragile X Fluorescein-Labelled Probe
Y1442
In Commercial Distribution

AGILENT TECHNOLOGIES, INC.
05700571112526
GS1

1
084963177 *Terms of Use
Fragile X Fluorescein-Labelled Probe
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
59482 Fragile X syndrome IVD, probe
A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used to evaluate a clinical specimen to diagnose, monitor or predict the inborn genetic disorder Fragile X syndrome. 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
MVU Reagents, specific, analyte
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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
Special Storage Condition, Specify: Protect from light
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 100 Microliter
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Device Record Status

9c4c9c55-5f85-4615-9329-c996b6e2007b
December 07, 2020
2
September 17, 2020
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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
05700571105368 5 05700571112526 In Commercial Distribution Box
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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

[?]
+1-805-566-6655
dako.usregulatory@agilent.com
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