DEVICE: STATSTRIP (00385480475525)

Device Identifier (DI) Information

STATSTRIP
Lactate
In Commercial Distribution
47552
NOVA BIOMEDICAL CORPORATION
00385480475525
GS1

4
070617139 *Terms of Use
Nova StatStrip LAC Linearity, Level 1, Level 2, Level 3, Level 4
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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
Lactate IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of lactate in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
JJY Multi-analyte controls, all kinds (assayed)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112955 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: Do not freeze.
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

93f97d57-5723-4aea-a41c-d06e78d40204
July 06, 2018
3
September 16, 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: 00385489475526 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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