Who else makes this device?

Name: Plasmaproteins Cal 3x
Brand: Plasmaproteins Cal 3x

Clinical Chemistry › Test SystemsCalibrator, Multi-Analyte Mixture

Plasmaproteins Cal 3x

Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the…

Registry build 21.09.26

Plasmaproteins Cal 3x must be used only for the calibration of the plasmaproteins tests listed in the Assigned Concentrations Table (TcA) using immunoturbidimetric methods. Use the calibrator according to the indicated analytical procedure. For in vitro diagnostic use only.

3manufacturers in China registered for this device type

2catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code JIX
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Getein Biotech, Inc.	Nanjing	Jiangsu	Manufacturer	19

Record

Regulatory record for Plasmaproteins Cal 3x
Listed by	Sentinel CH. SPA, Italy
FDA product code	JIX
Device type	Calibrator, Multi-Analyte Mixture
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
510(k)	K081533
Record published	2018-11-15
Record revised	2018-07-06 (version 3)

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	Special storage condition: Store between 2 and 8 degrees Celsius
Sizes	Total volume 4 ml

Catalogue Numbers

Catalogue numbers for Plasmaproteins Cal 3x
Catalogue number	Size	Status
11206D	Total Volume 4 ml	In distribution
A26854	Total Volume 4 ml	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	54
BioPlex 2200	Bio-Rad Laboratories Inc.	32
Plasma Calibrator Set	Chromsystems Instruments & Chemicals Gmbh	22
Phoenix Diagnostics	Phoenix Diagnostics, Inc.	20
Nova	Nova Biomedical Corporation	15
Plasma Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	15
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	15
Architect	Abbott Laboratories	11
Alinity	Abbott Medical	10
Synchron	Beckman Coulter, Inc.	9
Architect	Abbott Medical	9
Urine Calibration Standard	Chromsystems Instruments & Chemicals Gmbh	8

Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K081533	2008-06-25
K070971	2007-05-23
K051452	2005-10-25
K051457	2005-07-25

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.