Who else makes this device?

Name: TestOxidase Reagent (125ml)
Brand: TestOxidase Reagent (125ml)

Immunology & Microbiology › Microbiology DevicesDiscs, Strips And Reagents, Microorganism Differentiation

TestOxidase Reagent (125ml)

TestOxidase™ Reagent is a qualitative method for the determination of bacterial cytochrome oxidase.

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code JTO
Manufacturer	City	Province	Registered as	Device types
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25
Changchun LYZ Technology Co., Ltd.	Changchun	Jilin	Manufacturer	16
Zhejiang Joozena Medical Technology Co., Ltd.	Dongyang City, Jinhua	Zhejiang	Manufacturer	5

Record

Regulatory record for TestOxidase Reagent (125ml)
Listed by	pro-lab incorporated, Canada
FDA product code	JTO
Device type	Discs, Strips And Reagents, Microorganism Differentiation
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Contract manufacturer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-12-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for TestOxidase Reagent (125ml)
Catalogue number	Size	Status
PL.390-125		In distribution

Same Product Code

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Redipor	Analytichem USA, Inc.	7
BD BBL™ Taxo™ P	Becton, Dickinson AND Company	4
BD BBL™ Taxo™ A	Becton, Dickinson AND Company	4
API® NaCl 0.85% Medium	bioMerieux, Inc.	3
Bacticard	Remel, Inc.	3
Chemmette Reagents	Microbiologics, Inc.	2
Optochin	Oxoid, Ltd.	2
X Factor	Oxoid, Ltd.	2

Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K894221	1989-09-28
K861888	1986-06-03
K861889	1986-06-03

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.