Who else makes this device?

Name: Premier Ehec
Brand: Premier Ehec

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

Premier Ehec

The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps…

Registry build 21.09.26

The Premier EHEC test is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (Verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections.

3manufacturers in China registered for this device type

1catalogue number

1recall

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 Premier Ehec
Listed by	Meridian Bioscience, Inc., United States
FDA product code	GNA
Device type	Antisera, All Types, Escherichia Coli
Device class	Class 1
Regulation	21 CFR 866.3255
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2020-10-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Premier Ehec
Catalogue number	Size	Status
608096		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

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2016-11-08	Class II	Under Investigation by firm	Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.	4,747 EHEC + 180 EHEC Bulk	2017-08-16

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.