DEVICE: NOVA (10385480474860)
Device Identifier (DI) Information
NOVA
STATSTRIP LAC
In Commercial Distribution
47486
NOVA BIOMEDICAL CORPORATION
STATSTRIP LAC
In Commercial Distribution
47486
NOVA BIOMEDICAL CORPORATION
Nova StatStrip LAC Test Strips
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KHP | ACID, LACTIC, ENZYMATIC METHOD |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112955 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bd43dad3-6209-4b3a-9be8-1ab272bb3ca4
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00385480474863
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com