Teco Diagnostics Total Lipid Reagent Set

Teco Diagnostics Total Lipid Reagent Set is used for the quantitative determination of the total lipid index in serum using the sulfo-phospho-vanillin colorimetric method.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Jilin.

Chinese manufacturers registered for FDA product code CFD
Manufacturer City Province Registered as Device types
Dirui Industrial Co., Ltd. Changchun Jilin Contract manufacturer 84

Record

Regulatory record for Teco Diagnostics Total Lipid Reagent Set
Listed by Teco Diagnostics, United States
FDA product code CFD
Device type Sulfophosphovanillin, Colorimetry, Total Lipids
Device class Class 1
Regulation 21 CFR 862.1470
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-11-14

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 15 to 30 °C

Catalogue Numbers

Catalogue numbers for Teco Diagnostics Total Lipid Reagent Set
Catalogue number Size Status
T526-480 In distribution

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer