DEVICE: Galactose (with Membrane Plate) ELISA (00840239014887)
Device Identifier (DI) Information
Galactose (with Membrane Plate) ELISA
EIA-1488
Not in Commercial Distribution
EIA-1488
DRG International Inc
EIA-1488
Not in Commercial Distribution
EIA-1488
DRG International Inc
The DRG neonatal Galactose ELISA is designed for the quantitative determination of galactose in neonatal blood spots. It is for in vitro diagnostic use as an aid in screening newborns for elevated galactose levels as seen in galactosemia.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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59376 | Total galactose IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total galactose (galactose and galactose-1-phosphate) in a clinical specimen, using a spectrophotometry method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JIA | ENZYMATIC METHODS, GALACTOSE |
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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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d2e7d265-4be3-4537-b707-44f4c0234e72
July 26, 2023
3
June 07, 2021
July 26, 2023
3
June 07, 2021
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
[?]
+1(973)564-7555
corp@drg-international.com
corp@drg-international.com