Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Rheumatoid factor IVD, control FDA UDI
- Device Name
- Liquichek Rheumatoid Factor Control Level 3 (A human serum assayed rheumatoid factor control.) FDA UDI
- Model / Reference
- 503 FDA UDI
- Description
- Liquichek Rheumatoid Factor Control Level 3 (A human serum assayed rheumatoid factor control.) FDA UDI
Identifiers
- Catalog Number
- 503 FDA UDI
- Primary DI / UDI-DI
- 00847661001515 FDA UDI
- 510(k) Number
- K960987 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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
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: Rheumatoid factor IVD, control
Liquichek by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rheumatoid factor IVD, control.
- IMMUNO-TROL — THERADIAG SA
- Optilite® Rheumatoid Factor Control Pack — The Binding Site Group · Class I
- N/T Rheumatology Control SL/2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Audit MicroControls Linearity LQ RF/CRP — Aalto Scientific, Ltd.
- N/T Rheumatology Control SL/1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) — Randox Laboratories, Ltd. · Class I
- RF Control Set — Roche Diagnostics Corp. · Class II
- N/T Rheumatology Control SL/1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Cleared under the same submission
K960987 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 |
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Manufacturer
- Manufacturer
- Bio-Rad Laboratories
Sources (1)
- FDA UDI 52542ed4-ddc3-4054-ab38-c7f43fb0c00d 37 fields · synced May 30, 2026