DEVICE: Atellica CH UA (00630414596334)

Device Identifier (DI) Information

Atellica CH UA
11097608
In Commercial Distribution
11097608
Siemens Healthcare Diagnostics Inc.
00630414596334
GS1

1
064608573 *Terms of Use
Uric Acid (UA) Atellica CH - RGT 4800T
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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?
53583 Uric acid IVD, kit, spectrophotometry
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of uric acid in a clinical specimen, using a spectrophotometry method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KNK Acid, uric, uricase (colorimetric)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K991576 000
No 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 8 Degrees Celsius
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Clinically Relevant Size

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

89b9b897-c78f-43c7-b7af-243fe5280587
April 04, 2023
3
September 24, 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
No Package DIs found
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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

[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
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