DEVICE: Bartels® (05391516745949)
Device Identifier (DI) Information
Bartels®
B1029-47B
Not in Commercial Distribution
B1029-47B
TRINITY BIOTECH PUBLIC LIMITED COMPANY
B1029-47B
Not in Commercial Distribution
B1029-47B
TRINITY BIOTECH PUBLIC LIMITED COMPANY
Bartels® Herpes Simplex Virus Antigen Control Slides
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
52840 | Herpes simplex virus 1 & 2 (HSV1 & 2) antigen 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 antigens from herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
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 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 10 Slides |
Device Record Status
800cfaa3-1ed4-4b77-88a6-1f85268970e3
May 10, 2019
4
September 23, 2016
May 10, 2019
4
September 23, 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:
05391516748674
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+35312769800
Infectiousdisease.techsupport@trinitybiotech.com
Infectiousdisease.techsupport@trinitybiotech.com