Who else makes this device?

Name: Prolex E. coli O157 Latex Test Reagent Kit (100 tests)
Brand: Prolex E. coli O157 Latex Test Reagent Kit (100 tests)

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

Prolex E. Coli O157 Latex Test Reagent Kit (100 Tests)

ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony…

Registry build 21.09.26

ProlexTM E. coli O157 identifies Escherichia coli strains associated with Haemorrhagic Colitis and Haemolytic Uraemic Syndrome. Results can be obtained in two minutes from a single colony taken directly from selective agar. This unique reagent has been developed to remove common cross reactions with other similar “O” and “H” antigens, in particular E. hermanii. Available in 50 and 100 test formats, each kit has a maximum shelf life of two years from date of manufacture, and includes mixing sticks, agglutination cards, positive and negative controls.

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 O157 Latex Test Reagent Kit (100 tests)
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 O157 Latex Test Reagent Kit (100 tests)
Catalogue number	Size	Status
PL.071B		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.