Primary Device ID | 20816101027020 |
NIH Device Record Key | 57654034-f689-4cc7-9dfc-dc96b4be4d00 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Simplexa COVID-19 Direct |
Version Model Number | MOL4150 |
Catalog Number | MOL4150 |
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 | true |
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 | |
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 -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Storage Environment Temperature | Between -30 Degrees Celsius and -10 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 20816101027020 [Primary] |
QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-26 |
Device Publish Date | 2023-06-16 |
20816101027143 - Simplexa COVID-19 & Flu A/B Direct | 2023-07-03 |
20816101025835 - Simplexa Congenital CMV Direct | 2023-06-26 |
20816101025842 - Simplexa Congenital CMV Positive Control Pack | 2023-06-26 |
20816101027020 - Simplexa COVID-19 Direct | 2023-06-26 |
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 |
10816101025111 - Universal Disc Cover Tape | 2021-12-08 |