Identity
- Trade Name
- Liquichek FDA UDI
- Generic Name
- Sm/RNP antibody IVD, control FDA UDI
- Device Name
- Liquichek Anti-RNP Control, Positive (A pre-diluted human serum autoimmune control.) FDA UDI
- Model / Reference
- 116 FDA UDI
- Description
- Liquichek Anti-RNP Control, Positive (A pre-diluted human serum autoimmune control.) FDA UDI
Identifiers
- Catalog Number
- 116 FDA UDI
- Primary DI / UDI-DI
- 00847661000167 FDA UDI
- 510(k) Number
- K024223 FDA UDI
- FDA Product Code
- LKJ FDA UDI
- GMDN Term
- Sm/RNP antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 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: Sm/RNP antibody IVD, control
Liquichek by Bio-Rad Laboratories — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sm/RNP antibody IVD, control.
- Diamedix — Diamedix Corp. · Class II
- AUTO I.D.® Sm/RNP Autoantibody Test System — IMMUNO CONCEPTS INC
- Liquichek — Bio-Rad Laboratories · Class II
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 52971a1e-92b9-406a-8dbd-50045926429a 37 fields · synced May 30, 2026