cytovale.comIntelliSep test
Cytovale, Inc.
CYTOVALE, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017448032 | 3017448032 | CYTOVALE, INC. | 1 | N | 2026-01-01 | 2 Tower Pl Fl 18 South San Francisco CA US 94080 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860001900507 | Cytovale Reagent Kit - Cytovale Reagent Kit used to prepare the leukocyte suspension analyzed in the IntelliSep test by the Cytovale System. The two components in the Cytovale Reagent Kit: Reagent A (lysis solution w/ <1% formic acid) and Reagent B (quench w/ sodium carbonate). | 415-417-2188 | support@cytovale.com |
| 00860001900538 | IntelliSep Quality Control Kit - IntelliSep Quality Control Kit, a two-level quality control kit derived from stabilized whole blood for use with the IntelliSep test on the Cytovale System. | 415-417-2188 | support@cytovale.com |
| 00860001900583 | Cytovale Sample Preparation Module - The Sample Preparation Module (SPM) of the Cytovale System, used to prepare the patient specimen for analysis in the IntelliSep test. | 415-417-2188 | support@cytovale.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319810 | 1241778732 | K250912 | IntelliSep Test | QUT | 2025-11-19 |
| 319810 | 1158956120 | K220991 | IntelliSep test | QUT | 2022-12-20 |
| 319810 | 1135574136 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QUT | 2 | 2025-11-19 |
PMN
GUDID
Cytovale Reagent Kit - Cytovale Reagent Kit used to prepare the leukocyte suspension analyzed in the IntelliSep test by the Cytovale System. The two components in the Cytovale Reagent Kit: Reagent A (lysis solution w/ <1% formic acid) and Reagent B (quench w/ sodium carbonate).
2025-07-03
Cytovale Diluent - Cytovale Diluent, a reagent for use with the Sample Preparation Module to resuspend the leukocytes for subsequent analysis in the Cell Imaging Module (1x 1000 mL).
2025-07-03
Cytovale Cleanse - Cytovale Cleanse, a reagent for use with the Cytovale System's Sample Preparation Module for rinsing/cleaning parts that come into contact with the samples (1x 500mL).
2025-07-03
IntelliSep Quality Control Kit - IntelliSep Quality Control Kit, a two-level quality control kit derived from stabilized whole blood for use with the IntelliSep test on the Cytovale System.
2025-07-03
Cytovale Sample Preparation Module - The Sample Preparation Module (SPM) of the Cytovale System, used to prepare the patient specimen for analysis in the IntelliSep test.
2025-07-03
Cytovale Cell Imaging Module - The Cell Imaging Module (CIM) of the Cytovale System, used to directly image leukocytes under test for the IntelliSep test. Part of the Cytovale System.
2025-07-03
Cytovale Imaging Analysis Module - The Imaging Analysis Module (IAM) of the Cytovale System. Used to analyze images of the leukocytes under test.
2025-07-03
Cytovale Reagent Kit - Cytovale Reagent Kit used to prepare the leukocyte suspension for analysis in the IntelliSep test by the Cytovale System. The two components in the Cytovale Reagent Kit: Reagent A (lysis solution w/ <1% formic acid) and Reagent B (quench w/ sodium carbonate).
2025-07-03
IntelliSep Cartridge - IntelliSep Cartridge for use by the Cytovale Cell Imaging Module, part of the Cytovale System instrument. The cartridge provides a pathway for testing of each prepared blood sample. One cartridge is used for each test performed.
2025-07-03