Who else makes this device?

Name: Remel
Brand: Remel

Remel · Antigens, Cf (Including Cf Control), Influenza Virus A, B, C → Immunology & Microbiology

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GNX
Manufacturer	City	Province	Registered as	Device types
Hangzhou Rollmed Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	127

Record

Regulatory record for Remel
Listed by	Remel, Inc., United States
FDA product code	GNX
Device type	Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device class	Class 1
Regulation	21 CFR 866.3330
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published	2021-11-12
Record revised	2022-06-10 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for Remel
Catalogue number	Size	Per pack	Status
R246003		20	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QuickVue	Quidel Corp.	3
Status Flu A+B card	Princeton BioMeditech Corp.	3
BioSign Flu A+B card	Princeton BioMeditech Corp.	3
Poly stat	Polymedco, Inc.	2
McKesson	Mckesson Medical-Surgical Inc.	2
Antigens, Cf (Including Cf Control), Influenza Virus A, B, C	Zhengzhou Shiyi Biotech Co., Ltd.	2
Sofia	Quidel Corp.	2
OraSure Quick Flu 22-Count Flu A + B Kit	Orasure Technologies, Inc.	1
BD Veritor™ Plus Laboratory Combo Pack	Becton, Dickinson AND Company	1
Status Flu A+B Nasal Wash/Aspirate Kit	Princeton BioMeditech Corp.	1
Status Flu A & B	Princeton BioMeditech Corp.	1
Henry Schein	Henry Schein, Inc.	1

Showing 12 of 22. All products under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131804	2013-07-12

Recalls

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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
2013-02-19	Class III	Employee error	Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.	96 kits of 20 swab sets	2013-08-14

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.

Remel