Primary Device ID | 00812101031070 |
NIH Device Record Key | ddd91c6f-4db8-46b8-92c7-5225e7af6da3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARK™ Hydrocodone Assay |
Version Model Number | 5076-0001-01 |
Catalog Number | 5076-0001-01 |
Company DUNS | 164880598 |
Company Name | ARK DIAGNOSTICS INC |
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 | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.com | |
Phone | 5102706270 |
customersupport@ark-tdm.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 |
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 | 00812101031070 [Primary] |
DJG | Enzyme Immunoassay, Opiates |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-24 |
Device Publish Date | 2024-10-16 |
00812101031087 | The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se |
00812101031070 | The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se |
00812101031063 | The ARK™ Hydrocodone Assay is an immunoassay intended for the qualitative detection and/ or se |