TriVerity Level 1 Quality Control

The TriVerity Quality Controls are intended for use as optional quality control materials to assess the performance of the TriVerity Test System. TriVerity Quality Controls are designed to…

Registry build 21.09.26

The TriVerity Quality Controls are intended for use as optional quality control materials to assess the performance of the TriVerity Test System. TriVerity Quality Controls are designed to be used by laboratory personnel and healthcare professionals, according to individual organizational policies for quality control use when verifying or monitoring system performance. TriVerity Quality Controls are compatible for use with TriVerity cartridges used with the Myrna instrument.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JJY
Manufacturer City Province Registered as Device types
Getein Biotech, Inc. Nanjing Jiangsu Manufacturer 19

Record

Regulatory record for TriVerity Level 1 Quality Control
Listed by Inflammatix, United States
FDA product code JJY
Device type Multi-Analyte Controls, All Kinds (Assayed)
Device class Class 1
Regulation 21 CFR 862.1660
Establishment Manufacturer
Premarket notification Exempt
Record published 2026-04-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C; Handling environment atmospheric pressure 84.556 to 101.32 KiloPascal; Handling environment temperature 15 to 30 °C; Handling environment humidity 20 to 80 % RH
Packaging Box of 10

Catalogue Numbers

Catalogue numbers for TriVerity Level 1 Quality Control
Catalogue number Size Status
LEVEL 1 QUALITY CONTROL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Liquichek Bio-Rad Laboratories Inc. 154
Validate LGC Clinical Diagnostics, Inc. 120
InteliQ Bio-Rad Laboratories Inc. 50
Lyphochek Bio-Rad Laboratories Inc. 39
Stat Profile Nova Biomedical Corporation 38
i-STAT Abbott Point OF Care Inc. 24
Multichem AE Techno-Path Manufacturing Ltd. 20
Serum Control Chromsystems Instruments & Chemicals Gmbh 18
BioPlex 2200 Bio-Rad Laboratories Inc. 16
Nova Nova Biomedical Corporation 14
Plasma Control Chromsystems Instruments & Chemicals Gmbh 14
Multichem IA Speciality Techno-Path Manufacturing Ltd. 12

Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)

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

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer