DEVICE: AMIDO BLACK STAINING SOLUTION (03607360045541)

Device Identifier (DI) Information

AMIDO BLACK STAINING SOLUTION
4554
In Commercial Distribution
4554
SEBIA
03607360045541
GS1

1
276801933 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
57916 Citrate staining/testing reagent IVD
A citrate solution (citric acid solution) intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CEF Electrophoretic, Protein Fractionation
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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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: DO NOT FREEZE FRAGILE HANDLE WITH CARE PROTECT FROM HEAT THIS WAY UP
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

a6ee2686-db20-4be5-bb0f-a28397d56dbd
December 26, 2022
1
December 16, 2022
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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

[?]
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

[?]
No Customer Contact currently defined
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