Identity
- Trade Name
- iQ®200 FDA UDI
- Generic Name
- Urine sediment IVD, calibrator FDA UDI
- Device Name
- iQ Precision Kit FDA UDI
- Model / Reference
- iQ Precision Kit FDA UDI
- Description
- iQ Precision Kit FDA UDI
Identifiers
- Catalog Number
- 800-3014 FDA UDI
- Primary DI / UDI-DI
- 10837461002031 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
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Also classified as Urine sediment IVD, calibrator.
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- UF ll CALIBRATOR — Sysmex Corp. · Class I
- iQ®200 — BECKMAN COULTER IRELAND INC. · Class II
- iQ®200 — BECKMAN COULTER IRELAND INC. · Class I
- 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 |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
Sources (1)
- FDA UDI b91404cf-9bfa-4d7b-911f-30202b719de3 34 fields · synced Jun 8, 2026