DEVICE: STATSTRIP (00385480475525)
Device Identifier (DI) Information
STATSTRIP
Lactate
In Commercial Distribution
47552
NOVA BIOMEDICAL CORPORATION
Lactate
In Commercial Distribution
47552
NOVA BIOMEDICAL CORPORATION
Nova StatStrip LAC Linearity, Level 1, Level 2, Level 3, Level 4
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJY | Multi-analyte controls, all kinds (assayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K112955 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
93f97d57-5723-4aea-a41c-d06e78d40204
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00385489475526
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)545-6682
info@novabio.com
info@novabio.com