DEVICE: STA® - Deficient X (13607450007388)

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Device Record History
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Device Identifier (DI) Information
STA® - Deficient X
00738
In Commercial Distribution

DIAGNOSTICA STAGO
13607450007388
GS1

6
262277122 *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?
56034 Coagulation factor X IVD, kit, clotting
A collection of reagents and other associated materials intended to be used for the quantitative measurement of coagulation factor X in a clinical specimen, using a clotting method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GJT PLASMA, COAGULATION FACTOR DEFICIENT
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K933441 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
a9ff3dd2-e03a-46a6-9fb8-3050ac566298
May 03, 2021
4
September 15, 2016
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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: 03607450007381 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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