DEVICE: StatSensor (00385480440370)

Device Identifier (DI) Information

StatSensor
Creatinine
In Commercial Distribution
44037
NOVA BIOMEDICAL CORPORATION
00385480440370
GS1

5
070617139 *Terms of Use
StatSensor Creat Linearity Level 1 - 5
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Creatinine IVD, control A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of creatinine in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
JJX Single (specified) analyte controls (assayed and unassayed)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070068 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
Handling 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

80b3f5d6-a320-41fe-b22c-33b942b47fe9
July 06, 2018
3
September 20, 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: 00385489440371 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)545-6682
info@novabio.com
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