HerpeSelect® 1 ELISA IgG
GUDID 20816101022155
DIASORIN MOLECULAR LLC
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 20816101022155 |
| NIH Device Record Key | dc53cc81-64eb-4819-815b-3b94714c2938 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HerpeSelect® 1 ELISA IgG |
| Version Model Number | EL0910G-5 |
| Company DUNS | 080271715 |
| Company Name | DIASORIN MOLECULAR LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| DxTs@focusdx.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 562-240-6500 |
| TS.Molecular@DiaSorin.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20816101022155 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993754
FDA Product Code
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [HerpeSelect® 1 ELISA IgG]
| 20816101022155 | EL0910G-5 |
| 20816101022148 | EL0910G |
Trademark Results [HerpeSelect]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HERPESELECT 76239911 2684518 Live/Registered |
DIASORIN MOLECULAR LLC 2001-04-11 |
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