DEVICE: HemosIL Routine Control Level 2 (08426950573395)

Device Identifier (DI) Information

HemosIL Routine Control Level 2
00020005700
In Commercial Distribution
00020005700
INSTRUMENTATION LABORATORY COMPANY
08426950573395
GS1

10
557223252 *Terms of Use
HemosIL Routine Control Level 2
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
30590 Multiple coagulation factor IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GNN ANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1-24, B 1-6
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K082859 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Unopened control is stable until the expiration date shown on the vial when stored at 2-8°C.
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

7fd928a3-e382-4e7b-a6ed-58831326a49e
July 13, 2021
5
September 23, 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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 18426950573392 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-678-0710
techsupport.na@werfen.com
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