DEVICE: Enzygnost® TAT micro (00842768013065)
Device Identifier (DI) Information
Enzygnost® TAT micro
10446632
In Commercial Distribution
OWMG15
Siemens Healthcare Diagnostics Products GmbH
10446632
In Commercial Distribution
OWMG15
Siemens Healthcare Diagnostics Products GmbH
Quantitative determination of thrombin/antithrombin III complex (TAT) in human plasma
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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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? |
---|---|---|---|---|
56022 | Coagulation factor VIII IVD, kit, chromogenic |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor VIII in a clinical specimen, using a chromogenic method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JBQ | ANTITHROMBIN III QUANTITATION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K880700 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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
0f374b88-d0b8-4bfe-abef-f9aae6e97f58
November 18, 2021
5
September 24, 2016
November 18, 2021
5
September 24, 2016
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(800)242-3233
CONTACT@SIEMENS-HEALTHINEERS.COM
CONTACT@SIEMENS-HEALTHINEERS.COM