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ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, reagent FDA UDI
- Device Name
- In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL FDA UDI
- Model / Reference
- LDL1230 FDA UDI
- Description
- In Vitro Diagnostics testing kit R1:3X45mL, R2:3X15mL FDA UDI
Identifiers
- Catalog Number
- LDL1230 FDA UDI
- Primary DI / UDI-DI
- 00852169008201 FDA UDI
- FDA Product Code
- LBR FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 180 Milliliter FDA UDI
Category: Low density lipoprotein (LDL) cholesterol IVD, reagent
ClearChem Diagnostics Inc. Low-Density Lipoprotein (LDL) Cholesterol by Clearchem Diagnostics Inc. — Class I — FDA UDI — listed in FDA GUDID
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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
- Clearchem Diagnostics Inc.
Sources (1)
- FDA UDI b2a975e6-6285-498b-9d10-8eca6935bcb5 37 fields · synced Jun 8, 2026