Who else makes this device?

Name: Prolex E. coli Non-O157 Identification Kit
Brand: Prolex E. coli Non-O157 Identification Kit

Immunology & Microbiology › Serological ReagentsAntisera, All Types, Escherichia Coli

Prolex E. Coli Non-O157 Identification Kit

The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue…

Registry build 21.09.26

The ProlexTM E. coli Non-O157 Kit provides an easy to use, reliable and affordable way to identify the six most common STEC producing serotypes in North America. The kit uses our blue carboxylated latex particles labelled with antibodies to E. coli O26, E. coli O45, E. coli O103, E. coli O111, E. coli O121 and E. coli O145 to perform a simple agglutination test. This kit is a great addition to our line of products for the detection of STEC especially when used in conjunction with our ProlisaTM EHEC EIA Kit (PL.2001) and the ProlexTM E.coli O157 Latex Agglutination Kit (PL.070B and PL.071B). Each non-O157 kit comes with a negative control and sufficient agglutination cards and mixing sticks.

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Jilin.

Chinese manufacturers registered for FDA product code GNA
Manufacturer	City	Province	Registered as	Device types
Changchun Wancheng BIO-Electron Co., Ltd.	Changchun	Jilin	Contract manufacturer	34
Changchun Merydi BIO-Tech Co., Ltd.	Changchun	Jilin	Manufacturer	24
Jilin Hongyi BIO-Tech Co., Ltd.	Changchun	Jilin	Manufacturer	24

Record

Regulatory record for Prolex E. coli Non-O157 Identification Kit
Listed by	pro-lab incorporated, Canada
FDA product code	GNA
Device type	Antisera, All Types, Escherichia Coli
Device class	Class 1
Regulation	21 CFR 866.3255
Establishment	Contract manufacturer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-12-26

Specifications

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

Catalogue Numbers

Catalogue numbers for Prolex E. coli Non-O157 Identification Kit
Catalogue number	Size	Status
PL.1070		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Mast Assure Antisera	Mast Group Ltd.	7
E. coli O134 serum high titer, 1 mL	SSI Diagnostica A/S	2
Prolex E. coli O111 Latex Reagent	pro-lab incorporated	1
E. coli O73 serum high titer, 1 mL	SSI Diagnostica A/S	1
E. coli O25 serum, 1 mL	SSI Diagnostica A/S	1
E. coli O89 serum high titer, 1 mL	SSI Diagnostica A/S	1
ImmuLex E. coli O55, 1.5 mL	SSI Diagnostica A/S	1
E. coli O60 serum, 1 mL	SSI Diagnostica A/S	1
E. coli O10 serum high titer, 1 mL	SSI Diagnostica A/S	1
E. coli O110 serum, 1 mL	SSI Diagnostica A/S	1
E. coli O88 serum high titer, 1 mL	SSI Diagnostica A/S	1
E. coli O147 serum, 1 mL	SSI Diagnostica A/S	1

Showing 12 of 492. All products under Antisera, All Types, Escherichia Coli

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K903714	1991-01-24

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.