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Carolina Liquid Chemistries Corp.® Hdl Direct Cc615
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® HDL DIRECT CC615 FDA UDI
- Generic Name
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- HDLD W/CALIBRATOR, 2 X 200 tests FDA UDI
- Model / Reference
- CC615 FDA UDI
- Description
- HDLD W/CALIBRATOR, 2 X 200 tests FDA UDI
Identifiers
- Catalog Number
- CC615 FDA UDI
- Primary DI / UDI-DI
- 00817302022216 FDA UDI
- FDA Product Code
- LBS FDA UDILBR FDA UDI
- GMDN Term
- High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry 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
No
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
Yes
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 — 20 Milliliter FDA UDITotal Volume — 60 Milliliter FDA UDITotal Volume — 3 Milliliter FDA UDI
Category: High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry
Carolina Liquid Chemistries Corp.® Hdl Direct Cc615 by Carolina Liquid Chemistries Corp. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry.
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- ENVOY 500 HDL CHOLESTEROL REAGENT KIT — VITALSCIENTIFIC
- HDL Ultra Cholesterol — Sekisui Diagnostics, LLC · Class I
- ABX PENTRA HDL DIRECT CP — Horiba Abx · Class I
- Sirrus® Direct HDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- Dimension Vista® Flex® reagent cartridge HDLC — Siemens Healthcare Diagnostics · Class I
- Ultra N-geneous HDL Cholesterol Reagent — Sekisui Diagnostics, LLC · 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
- Carolina Liquid Chemistries Corp.
Sources (1)
- FDA UDI bf4ce648-bb81-48aa-8ced-0bdbcaf7d00f 37 fields · synced May 31, 2026