Who else makes this device?

Name: E. coli O35 serum, 1 mL
Brand: E. coli O35 serum, 1 mL

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

E. Coli O35 Serum, 1 Ml

Catalogue number 85032, listed by SSI Diagnostica A/S, Denmark, under Antisera, All Types, Escherichia Coli. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

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 E. coli O35 serum, 1 mL
Listed by	SSI Diagnostica A/S, Denmark
FDA product code	GNA
Device type	Antisera, All Types, Escherichia Coli
Device class	Class 1
Regulation	21 CFR 866.3255
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2021-08-11

Specifications

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

Catalogue Numbers

Catalogue numbers for E. coli O35 serum, 1 mL
Catalogue number	Size	Status
85032		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

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.