DEVICE: CAPILLARYS 3 DBS MICROPLATES (03607360025789)
Device Identifier (DI) Information
CAPILLARYS 3 DBS MICROPLATES
2578
In Commercial Distribution
2578
SEBIA
2578
In Commercial Distribution
2578
SEBIA
MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
61296 | Microplate IVD |
A plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKA | Abnormal Hemoglobin Quantitation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K232027 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 30 Degrees Celsius |
Special Storage Condition, Specify: This Way Up_Fragile-handle with care_Keep Dry |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ff4a5226-c102-4788-853c-839f98b35cfa
May 08, 2024
1
April 30, 2024
May 08, 2024
1
April 30, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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