SEFRIA™
GUDID 00840937112120
SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 100
IMMUNALYSIS CORPORATION
Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),| Primary Device ID | 00840937112120 |
| NIH Device Record Key | 7c2d214c-918f-4a6f-a19e-21e51f578581 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEFRIA™ |
| Version Model Number | 612OF-0100 |
| Company DUNS | 080589004 |
| Company Name | IMMUNALYSIS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.com | |
| Phone | +1(909)482-0840 |
| info@immunalysis.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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840937112120 [Primary] |
FDA Product Code
| PVA | Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-08 |
| Device Publish Date | 2021-09-30 |
On-Brand Devices [SEFRIA™]
| 00840937112137 | SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 500 |
| 00840937112120 | SEFRIA™ Cocaine/Benzoylecgonine Oral Fluid Kit 100 |
Trademark Results [SEFRIA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEFRIA 85685896 4927765 Live/Registered |
Advanced ImmunoAssays LLC 2012-07-24 |
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