Who else makes this device?

Name: Vitros
Brand: Vitros

Vitros · Electrode, Ion-Specific, Chloride → Clinical Chemistry

2manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code CGZ
Manufacturer	City	Province	Registered as	Device types
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56

Record

Regulatory record for Vitros
Listed by	Ortho-Clinical Diagnostics, Inc., United States
FDA product code	CGZ
Device type	Electrode, Ion-Specific, Chloride
Device class	Class 2
Regulation	21 CFR 862.1170
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2016-08-10
Record revised	2023-06-21 (version 4)

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 2 to 8 °C
Packaging	Case of 30

Catalogue Numbers

Catalogue numbers for Vitros
Catalogue number	Size	Status
8445207		In distribution
6844471		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Stat Profile	Nova Biomedical Corporation	14
Nova	Nova Biomedical Corporation	8
Architect	Abbott Laboratories	6
Chloride Electrode	Roche Diagnostics Gmbh	3
Chloride Electrode	Medica Corp.	3
Chloride Electrode	Diamond Diagnostics Inc.	3
I.S.E. CL	Randox Laboratories Limited	2
Phoenix Diagnostics, Inc.	Phoenix Diagnostics, Inc.	2
Na/K/Cl Solution Pack	Medica Corp.	2
Ready Sensor™ Gold Reference Sensor Refill	Siemens Healthcare Diagnostics Inc	1
I.S.E. REF	Randox Laboratories Limited	1
ABL90 Flex Plus	Radiometer Medical APS	1

Showing 12 of 51. All products under Electrode, Ion-Specific, Chloride

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K182072	2018-10-30
K162020	2016-12-16
K082099	2008-08-21

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2019-09-10	Class II	Process control	Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.	1365545 total	2020-11-13
2019-09-10	Class II	Process control	Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.	1365545 total	2020-11-13
2018-07-11	Class III	Under Investigation by firm	The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples when tested with the Cl- slide is not af	168919	2020-08-11
2018-07-11	Class III	Under Investigation by firm	The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the	128196	2020-08-11

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.

Vitros