DEVICE: SPOTCHECK (00725609000038)
Device Identifier (DI) Information
SPOTCHECK
80-3500-13K
In Commercial Distribution
80-3500-13K
ASTORIA-PACIFIC, INC.
80-3500-13K
In Commercial Distribution
80-3500-13K
ASTORIA-PACIFIC, INC.
G6PD 25 Hour Reagent Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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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? |
---|---|---|---|---|
55932 | Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme fluorescence |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells from a clinical specimen, using an enzyme fluorescence method.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JBL | Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K990957 | 000 |
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
ada5b20a-4042-4585-b3ad-dcf07111a4fd
July 06, 2018
3
October 14, 2016
July 06, 2018
3
October 14, 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