MicroTrak®
- Primary DI
- 05391516746007
- Brand
- MicroTrak®
- Company
- TRINITY BIOTECH PUBLIC LIMITED COMPANY
- Model
- 8H219UL
- Catalog number
- 8H219UL
- Device description
- MicroTrak® HSV-1/HSV-2 Culture Identification/Typing Test
- Published
- 2016-09-23
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Contact Domains#
trinitybiotech.comProduct Codes#
| Code | Name |
|---|---|
| GON | Antigen, Cf (Including Cf Control), Rubella |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| GON | Antigen, Cf (Including Cf Control), Rubella | Microbiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K880157 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 05391516746007 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 05391516746007 | 05391516746007 | 5391516746007 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 2 Degrees Celsius | 8 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +35312769800 | Infectiousdisease.techsupport@trinitybiotech.com |
Regulatory Flags#
- DUNS number
- 988298840
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 05391516741927 | Trinity Biotech | 450-A | 450-A | 2016-09-23 |
| 05391516742238 | Trinity Biotech | 591-C | 591-C | 2017-10-06 |
| 05391516742245 | Trinity Biotech | 591-D | 591-D | 2017-10-06 |
| 05391516746106 | Uni-Gold™ | 1206506 | 1206506 | 2016-09-23 |
| 05391516746113 | Uni-Gold™ | 1206530 | 1206530 | 2016-09-23 |
| 05391516742290 | Trinity Biotech | 826-10 | 826-10 | 2016-09-23 |
| 05391516745161 | Bartels® | B1029-81A | B1029-81A | 2016-09-23 |
| 05391516745826 | Bartels® | B1029-44 | B1029-44 | 2016-09-23 |
| 05391516745864 | Bartels® | B1029-44C | B1029-44C | 2016-09-23 |
| 05391516745871 | Bartels® | B1029-81 | B1029-81 | 2016-09-23 |
| 05391516745888 | Bartels® | B1029-81B | B1029-81B | 2016-09-23 |
| 05391516745901 | Bartels® | B1029-91 | B1029-91 | 2016-09-23 |
| 05391516745918 | Bartels® | B1029-47 | B1029-47 | 2016-09-23 |
| 05391516745925 | Bartels® | B1029-47C | B1029-47C | 2016-09-23 |
| 05391516745932 | Bartels® | B1029-48 | B1029-48 | 2016-09-23 |
| 05391516745949 | Bartels® | B1029-47B | B1029-47B | 2016-09-23 |
| 05391516746038 | MicroTrak® | 8H349UL | 8H349UL | 2016-09-23 |
| 05391516746144 | MicroTrak® | 8H399UL | 8H399UL | 2016-09-23 |
| 05391516748643 | MicroTrak® | 8H329UL | 8H329UL | 2016-09-23 |
| 05391516741521 | Trinity Biotech | 203-A | 203-A | 2016-09-23 |