DEVICE: NOVA (00385480417419)
Device Identifier (DI) Information
NOVA
STATSTRIP XPRESS GLU
In Commercial Distribution
41741
NOVA BIOMEDICAL CORPORATION
STATSTRIP XPRESS GLU
In Commercial Distribution
41741
NOVA BIOMEDICAL CORPORATION
StatStrip StatStrip Xpress GLU Control Level 1
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
41819 | Glucose IVD, control |
A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JJX | Single (specified) analyte controls (assayed and unassayed) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Special Storage Condition, Specify: Do not refrigerate or freeze |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b1d6a0c8-2a94-4571-b2ab-fbfdcdcb06db
March 29, 2018
2
September 20, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(180)054-5668
info@novabio.com
info@novabio.com