Primary Device ID | 10816101022295 |
NIH Device Record Key | 7ede9131-ba2d-430f-8a62-143d89159949 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DxSelect™ - Substrate Reagent |
Version Model Number | EL0009 |
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 | false |
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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 10816101022295 [Primary] |
MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2023-06-02 |
Device Publish Date | 2017-07-11 |
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20816101027020 - Simplexa COVID-19 Direct | 2023-06-26 |
20816101027037 - Simplexa COVID-19 Positive Control Pack | 2023-06-26 |
20816101027150 - Simplexa COVID-19 & Flu A/B Positive Control Pack | 2023-06-26 |
10816101022295 - DxSelect™ - Substrate Reagent | 2023-06-02 |
10816101022295 - DxSelect™ - Substrate Reagent | 2023-06-02 |
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