Identity
- Trade Name
- COULTER Lyse S III diff Lytic Reagent FDA UDI
- Generic Name
- Full blood count IVD, reagent FDA UDI
- Device Name
- COULTER Lyse S III diff Lytic Reagent (1L) FDA UDI
- Model / Reference
- 8546983 FDA UDI
- Description
- COULTER Lyse S III diff Lytic Reagent (1L) FDA UDI
Identifiers
- Catalog Number
- 8546983 FDA UDI
- Primary DI / UDI-DI
- 15099590625887 FDA UDI
- FDA Product Code
- GGK FDA UDI
- GMDN Term
- Full blood count IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8540 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Full blood count IVD, reagent
COULTER Lyse S III diff Lytic Reagent by Beckman Coulter, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full blood count IVD, reagent.
- Swelab Lumi-L2 Lyse — Boule Medical AB · Class I
- BD FACSFlow — BECTON DICKINSON AND COMPANY · Class I
- Medonic M51-D Diluent — Boule Medical AB · Class I
- ADVIA® 120/2120/2120i CSF REAGENT — Siemens Healthcare Diagnostics · Class II
- Medonic M51-L2 Lyse — Boule Medical AB · Class I
- ADVIA 120/2120/2120i® Perox Sheath — Siemens Healthcare Diagnostics · Class II
- ADVIA 120/2120/2120i® Defoamer — Siemens Healthcare Diagnostics · Class II
- Swelab Lumi-L1 Lyse — Boule Medical AB · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Beckman Coulter, Inc.
Sources (1)
- FDA UDI f7643631-ee28-46ca-87ca-6b80b9fdec98 35 fields · synced Jun 8, 2026