Identity
- Trade Name
- CDS-LTX CONTROL FDA UDI
- Generic Name
- Reticulocyte count IVD, control FDA UDI
- Device Name
- CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements. Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter. FDA UDI
- Model / Reference
- 6 x 16 mL FDA UDI
- Description
- CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements. Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter. FDA UDI
Identifiers
- Catalog Number
- 502-006 FDA UDI
- Primary DI / UDI-DI
- 00812137010254 FDA UDI
- 510(k) Number
- K993375 FDA UDI
- FDA Product Code
- KRX FDA UDI
- GMDN Term
- Reticulocyte count IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Reticulocyte count IVD, control
Cds-Ltx Control by Clinical Diagnostic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reticulocyte count IVD, control.
- Liquichek — Bio-Rad Laboratories · Class II
- ADVIA® 120/2120/2120i TESTpoint Retic High Control — Siemens Healthcare Diagnostics · Class II
- Retic-Chex Linearity BC — Streck · Class II
- Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Class II
- Retic-Chex II — Streck · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
Cleared under the same submission
K993375 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clinical Diagnostic Solutions, Inc.
Sources (1)
- FDA UDI 1d5a7200-7d5d-4cda-9a8d-6faa743dac5f 37 fields · synced May 30, 2026