← Back to catalogue
Carolina Liquid Chemistries Corp.® Ldl Cholesterol Direct Reagent Kit St661
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- CAROLINA LIQUID CHEMISTRIES CORP.® LDL CHOLESTEROL DIRECT REAGENT KIT ST661 FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- LDL Cholesterol Reagent (LDL) w/ Calibrator FDA UDI
- Model / Reference
- ST661 FDA UDI
- Description
- LDL Cholesterol Reagent (LDL) w/ Calibrator FDA UDI
Identifiers
- Catalog Number
- ST661 FDA UDI
- Primary DI / UDI-DI
- 00817302024623 FDA UDI
- FDA Product Code
- MRR FDA UDI
- GMDN Term
- Low density lipoprotein (LDL) 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
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
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDITotal Volume — 44 Milliliter FDA UDITotal Volume — 16 Milliliter FDA UDI
Category: Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry
Carolina Liquid Chemistries Corp.® Ldl Cholesterol Direct Reagent Kit St661 by Carolina Liquid Chemistries Corp. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry.
- Sirrus® Direct LDL Cholesterol LiquiColor® — STANBIO LABORATORY, L.P. · Class I
- LDL Direct LS Cholesterol Reagent Kit — Sekisui Diagnostics, LLC · Class I
- N-geneous LDL-ST Cholesterol Reagent (R1) — Sekisui Diagnostics, LLC · Class I
- LDL CHOL Reagent Kit — Medica Corp. · Class I
- CHOLESTEROL LDL SL 2G — VITALSCIENTIFIC
- DIRECT LDL-CHOLESTEROL (LDL) — Randox Laboratories, Ltd. · Class I
- LDL-Cholesterol Gen.3 — Roche Diagnostics Corp. · Class I
- Pointe Scientific, Inc. autoLDL Cholesterol — POINTE SCIENTIFIC, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carolina Liquid Chemistries Corp.
Sources (1)
- FDA UDI 4e64ba6c-579a-41b8-a737-79ef5b695d6d 37 fields · synced May 30, 2026