Who else makes this device?

Name: CueSee® Co-OX
Brand: CueSee® Co-OX

Hematology › ReagentsControl, Hemoglobin

CueSee® Co-OX

CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is…

Registry build 21.09.26

CueSee® CO-OX LVA is an assayed quality control material for professional use to verify the performance characteristics of the Radiometer ABL800 FLEX series analyzer. CueSee® COOX is intended for the quantitative determination of total hemoglobin (tHb), fraction of oxygenated hemoglobin (FO2Hb), fraction of carboxyhemoglobin (FCOHb) and fraction of methemoglobin (FMetHb). CueSee® CO-OX is intended for professional users (medical and laboratory personnel) in clinical settings (e.g. hospital or laboratory). CueSee® CO-OX LVA contains: 1 bottle of CueSee® CO-OX S1A (DI: 08718734961000), 1 bottle of CueSee® CO-OX S2A (DI: 08718734961017), 1 bottle of CueSee® CO-OX S3A (DI: 08718734961024), 1 bottle of CueSee® CO-OX S4A (DI: 08718734961031) and 1 bottle of CueSee® CO-OX S5A (DI: 08718734961048).

2manufacturers in China registered for this device type

11catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GGM
Manufacturer	City	Province	Registered as	Device types
Acon Biotech (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Urit Medical Electronic Co., Ltd.	Guilin	Guangxi	Contract manufacturer	28

Record

Regulatory record for CueSee® Co-OX
Listed by	Eurotrol B.V., Netherlands
FDA product code	GGM
Device type	Control, Hemoglobin
Device class	Class 2
Regulation	21 CFR 864.8625
Establishment	Contract manufacturer, Manufacturer
Premarket notification	Exempt
Record published	2021-12-19

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Box of 5

Catalogue Numbers

Catalogue numbers for CueSee® Co-OX
Catalogue number	Size	Status
S5B		In distribution
LVA		In distribution
S1A		In distribution
S5A		In distribution
LVB		In distribution
S4B		In distribution
S6B		In distribution
S2B		In distribution
S3A		In distribution
S1B		In distribution
S3B		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Eurotrol	Eurotrol B.V.	11
Research and Diagnostic Systems	Research AND Diagnostic Systems, Inc.	10
Liquichek	Bio-Rad Laboratories Inc.	8
InteliQ	Bio-Rad Laboratories Inc.	4
Hemoglobin Test Strip	Urit Medical Electronic Co., Ltd.	3
HemoTrol Duo	Eurotrol B.V.	3
Lyphochek	Bio-Rad Laboratories Inc.	3
McKesson	Mckesson Medical-Surgical Inc.	3
HemoTrol WB	Eurotrol B.V.	3
Hemoglobin Control Solution	Urit Medical Electronic Co., Ltd.	3
Hemoglobin Meter	Urit Medical Electronic Co., Ltd.	2
Henry Schein	Henry Schein, Inc.	1

Showing 12 of 25. All products under Control, Hemoglobin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K192842	2019-11-15
K182744	2019-02-01

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.