DEVICE: CAPILLARYS 3 DBS MICROPLATES (03607360025789)

Device Identifier (DI) Information

CAPILLARYS 3 DBS MICROPLATES
2578
In Commercial Distribution
2578
SEBIA
03607360025789
GS1

1
276801933 *Terms of Use
MICROPLATES ARE AN ACCESSORY _PLASTIC PLATES
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GKA Abnormal Hemoglobin Quantitation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K232027 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: This Way Up_Fragile-handle with care_Keep Dry
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ff4a5226-c102-4788-853c-839f98b35cfa
May 08, 2024
1
April 30, 2024
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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
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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