DEVICE: Serum Control (04250317543462)

Device Identifier (DI) Information

Serum Control
0027
In Commercial Distribution
0027
Chromsystems Instruments + Chemicals GmbH
04250317543462
GS1

1
328712260 *Terms of Use
Serum Control Level II, ß-Carotene in serum/plasma
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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?
54438 Vitamin A IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of vitamin A in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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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: less than -18 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 5 x 2ml
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Device Record Status

a64356f4-1c56-402c-9f24-b09664cf932b
August 05, 2022
2
July 30, 2020
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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
04250317504715 5 04250317543462 In Commercial Distribution
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Secondary DI

[?]
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

[?]
+4989189300
mailbox@chromsystems.de
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