Immunalysis QS-76501
GUDID 00840937103142
Quantisal Saliva Collection Device -100 Per Box, Specimen Bag - 100 Per Box
IMMUNALYSIS CORPORATION
Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit Oral/upper respiratory tract specimen collection kit| Primary Device ID | 00840937103142 |
| NIH Device Record Key | 7924e01b-57f4-4d72-8980-38a3a403ec43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Immunalysis |
| Version Model Number | QS-76501 |
| Catalog Number | QS-76501 |
| Company DUNS | 080589004 |
| Company Name | IMMUNALYSIS CORPORATION |
| Device Count | 100 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840937103142 [Unit of Use] |
| GS1 | 00840937113912 [Primary] |
| GS1 | 00840937113929 [Primary] |
| GS1 | 00840937113936 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K942435
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 | 2023-04-06 |
| Device Publish Date | 2023-03-29 |
Devices Manufactured by IMMUNALYSIS CORPORATION
| 00840937103265 - Immunalysis Corporation | 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 1 |
| 00840937103272 - Immunalysis Corporation | 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 2 |
| 00840937103289 - Immunalysis Corporation | 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 3 |
| 00840937103296 - Immunalysis Corporation | 2023-11-03 Cannabinoid Oral Fluid Calibrator Level 4 |
| 00840937103302 - Immunalysis Corporation | 2023-11-03 Cannabinoid Oral Fluid Control Set |
| 00840937111864 - Immunalysis Corporation | 2023-11-02 SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 100mL Kit |
| 00840937111871 - Immunalysis Corporation | 2023-11-02 SEFRIA 6-Acetylmorphine Oral Fluid Enzyme Immunoassay 500mL Kit |
| 00840937112007 - Immunalysis Corporation | 2023-11-02 SEFRIA Amphetamine Oral Fluid Enzyme Immunoassay 100mL Kit |
Trademark Results [Immunalysis]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMUNALYSIS 86270142 4652770 Live/Registered |
Alere San Diego, Inc. 2014-05-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.