Quantisal QSII-0025
GUDID 00840937112144
Quantisal II Oral Fluid Collection Device 25pk
IMMUNALYSIS CORPORATION
Oral specimen collection kit, transport medium| Primary Device ID | 00840937112144 |
| NIH Device Record Key | 287e0aee-b855-489d-b706-ab62f459e70c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Quantisal |
| Version Model Number | QSII-0025 |
| Catalog Number | QSII-0025 |
| Company DUNS | 080589004 |
| Company Name | IMMUNALYSIS CORPORATION |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com | |
| Phone | 909-482-0840 |
| info@immunalysis.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840937112144 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183048
FDA Product Code
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
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 | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
On-Brand Devices [Quantisal]
| 00840937112168 | Quantisal Oral Fluid Collection Device 500pk |
| 00840937112151 | Quantisal Oral Fluid Collection Device 25 pk |
| 00840937112144 | Quantisal II Oral Fluid Collection Device 25pk |
| 00840937112069 | Quantisal II Product Box |
| 00840937112052 | Quantisal I (25/100) Test |
Trademark Results [Quantisal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTISAL 86270179 4652773 Live/Registered |
Alere San Diego, Inc. 2014-05-02 |
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