DEVICE: NOVA (10385480474860)

Device Identifier (DI) Information

NOVA
STATSTRIP LAC
In Commercial Distribution
47486
NOVA BIOMEDICAL CORPORATION
10385480474860
GS1

25
070617139 *Terms of Use
Nova StatStrip LAC Test Strips
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
53345 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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KHP ACID, LACTIC, ENZYMATIC METHOD
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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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not freeze
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

bd43dad3-6209-4b3a-9be8-1ab272bb3ca4
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
20385480474867 2 10385480474860 In Commercial Distribution carton
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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: 00385480474863 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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