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C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV) FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, control FDA UDI
- Device Name
- C-Reactive Protein Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for C-reactive protein (CRP). FDA UDI
- Model / Reference
- LV10334 FDA UDI
- Description
- C-Reactive Protein Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for C-reactive protein (CRP). FDA UDI
Identifiers
- Catalog Number
- LV10334 FDA UDI
- Primary DI / UDI-DI
- 05055273216226 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, control 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: C-reactive protein (CRP) IVD, control
C-REACTIVE PROTEIN LINEARITY VERIFIERS (For Roche Series) (CPLV) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as C-reactive protein (CRP) IVD, control.
- ASI CRP Control Set — Arlington Scientific, Inc. · Class II
- K-ASSAY® hsCRP Control — KAMIYA BIOMEDICAL COMPANY, LLC · Class I
- Audit MicroControls Linearity LQ hs-CRP — Aalto Scientific, Ltd.
- Diazyme — Diazyme Laboratories, Inc.
- POINTE SCIENTIFIC CRP Control Set — POINTE SCIENTIFIC, INC. · Class II
- IMMULITE® Systems CRP CONTROL C-Reactive Protein — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- DImension Vista® High Sensitivity CRP Control H (high) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — Abbott Laboratories, 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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI ef2f7dac-eb79-46ea-9049-df295c4d14b7 36 fields · synced May 30, 2026