Identity
- Trade Name
- iQ®200 FDA UDI
- Generic Name
- Urine sediment IVD, calibrator FDA UDI
- Device Name
- iQ® Calibrator Pack FDA UDI
- Model / Reference
- iQ® Calibrator FDA UDI
- Description
- iQ® Calibrator Pack FDA UDI
Identifiers
- Catalog Number
- 800-3103 FDA UDI
- Primary DI / UDI-DI
- 10837461002147 FDA UDI
- FDA Product Code
- JJW FDA UDI
- GMDN Term
- Urine sediment IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Urine sediment IVD, calibrator
iQ®200 by Beckman Coulter Ireland Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine sediment IVD, calibrator.
- Urine Chemistry Standard Kit — VERICHEM LABORATORIES, INC. · Class II
- UF-CALIBRATOR — Sysmex Corp. · Class II
- UF ll CALIBRATOR — Sysmex Corp. · Class I
- iQ®200 — BECKMAN COULTER IRELAND INC. · Class I
- iQ®200 — BECKMAN COULTER IRELAND INC. · Class II
- iQ®200 — BECKMAN COULTER IRELAND INC. · 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 Ireland Inc.
Sources (1)
- FDA UDI a8e5ebaf-4a16-40ef-884d-86b4de90a962 34 fields · synced May 31, 2026