Who else makes this device?

Name: RapID
Brand: RapID

RapID · Discs, Strips and Reagents, Microorganism Differentiation → Immunology & Microbiology

4manufacturers in China registered for this device type

1catalogue number

49510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Jiangsu (1), Shandong (1), Jilin (1).

Chinese manufacturers registered for FDA product code JTO
Manufacturer	City	Province	Registered as	Device types
Hospital & Homecare IMP. & EXP. Co., Ltd.	Nanjing	Jiangsu	Contract manufacturer	179
Jinan Babio Biotechnology Co., Ltd.	Jinan	Shandong	Manufacturer	25
Changchun LYZ Technology Co., Ltd.	Changchun	Jilin	Manufacturer	16
Zhejiang Joozena Medical Technology Co., Ltd.	Dongyang City, Jinhua	Zhejiang	Manufacturer	5

Record

Regulatory record for RapID
Listed by	Remel, Inc., United States
FDA product code	JTO
Device type	Discs, Strips And Reagents, Microorganism Differentiation
Device class	Class 1
Regulation	21 CFR 866.2660
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2022-12-23
Record revised	2025-05-06 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Distribution end date	2025-05-05

Catalogue Numbers

Catalogue numbers for RapID
Catalogue number	Size	Status
R4653047		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Remel	Remel, Inc.	62
Discs, Strips And Reagents, Microorganism Differentiation	Hardy Diagnostics	37
HardyDisk™	Hardy Diagnostics	17
Bactidrop	Remel, Inc.	10
Redipor	Analytichem USA, Inc.	7
BD BBL™ Taxo™ P	Becton, Dickinson AND Company	4
BD BBL™ Taxo™ A	Becton, Dickinson AND Company	4
API® NaCl 0.85% Medium	bioMerieux, Inc.	3
Bacticard	Remel, Inc.	3
Chemmette Reagents	Microbiologics, Inc.	2
Optochin	Oxoid, Ltd.	2
X Factor	Oxoid, Ltd.	2

Showing 12 of 139. All products under Discs, Strips And Reagents, Microorganism Differentiation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K970832	1997-04-24
K970834	1997-04-17
K970833	1997-04-02
K936021	1994-05-20
K934986	1994-02-23
K933514	1993-10-28
K930878	1993-05-11
K923700	1992-10-05
K923827	1992-09-28
K920973	1992-06-19
K920971	1992-05-22
K920972	1992-05-22
K920257	1992-04-22
K913008	1991-09-23
K913002	1991-09-23
K913007	1991-09-23
K913003	1991-09-23
K913006	1991-09-23
K913011	1991-09-19
K913010	1991-09-19
K913001	1991-09-18
K913009	1991-09-18
K913004	1991-09-18
K905163	1991-02-20
K905151	1991-01-25
K902595	1990-10-02
K880950	1988-04-01
K861259	1986-04-11
K852886	1985-07-23
K844020	1984-12-13
K844019	1984-10-31
K843987	1984-10-30
K840686	1984-04-13
K840708	1984-04-13
K840614	1984-04-13
K840819	1984-03-23
K840483	1984-03-02
K834022	1983-12-30
K834029	1983-12-30
K833963	1983-12-30
K834028	1983-12-30
K830323	1983-02-28
K812084	1981-08-13
K812083	1981-08-13
K812082	1981-08-13
K810541	1981-03-17
K801493	1980-08-13
K801492	1980-08-13
K790038	1979-01-26

Recalls

2 of these are 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
2013-05-02	Class II	Process control	The product may give weak or false negative test results.	109 kits	2014-03-12
2013-05-02	Class II	Process control	The product may give weak or false negative test results.	768 kits	2014-03-12

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.

RapID