DEVICE: Atellica CH CHE (00630414596273)
Device Identifier (DI) Information
Atellica CH CHE
11097615
Not in Commercial Distribution
11097615
Siemens Healthcare Diagnostics Inc.
11097615
Not in Commercial Distribution
11097615
Siemens Healthcare Diagnostics Inc.
Cholinestrase (CHE) Atellica CH - RGT 270T
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? |
---|---|---|---|---|
52964 | Acetylcholinesterase IVD, kit, spectrophotometry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the enzyme acetylcholinesterase in a clinical specimen, using a spectrophotometry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DIH | Colorimetry, cholinesterase |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013750 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Reagent Preparation Step |
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e4fcfc53-affc-4e88-b2ef-1e7c1731b0c6
November 06, 2024
4
September 24, 2020
November 06, 2024
4
September 24, 2020
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
[?]
+1(877)229-3711
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM