DEVICE: MicroTrak® (05391516748643)
Device Identifier (DI) Information
MicroTrak®
8H329UL
Not in Commercial Distribution
8H329UL
TRINITY BIOTECH PUBLIC LIMITED COMPANY
8H329UL
Not in Commercial Distribution
8H329UL
TRINITY BIOTECH PUBLIC LIMITED COMPANY
MicroTrak® HSV 1 /HSV 2 Direct Specimen - Collection Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
49537 | Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay |
A collection of reagents and other associated materials 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, using a fluorescent immunoassay method.
|
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 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1 Kit |
Device Record Status
1668852c-2028-4295-9f4e-5a7a21b90cef
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 |
---|---|---|---|---|---|
05391516746137 | 20 | 05391516748643 | 2019-01-01 | Not in Commercial Distribution |
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
[?]
+35312769800
Infectiousdisease.techsupport@trinitybiotech.com
Infectiousdisease.techsupport@trinitybiotech.com