Remel Cleveland, A Division of Remel Inc.

Matched from indexed company URL: REMEL INC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1530126	1000515493	Remel Cleveland, A Division of Remel Inc.	1	Y	2026-01-01	1 Thermo Fisher Way Oakwood Village OH US 44146
1924669	1924669	REMEL, INC.	1	Y	2026-01-01	12076 Santa Fe Trail Dr LENEXA KS US 66215
3003750284	3003750284	REMEL EUROPE LTD	1	N	2026-01-01	REMEL HOUSE, CLIPPER BLVD. WEST CROSSWAYS DARTFORD, KENT Kent GB DA2 6PT
1031428	1031428	REMEL ATLANTA, A DIV. OF REMEL, INC.	1	N	2020-04-25	2797 Peterson Pl NORCROSS GA US 30071

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00848838018855	NA - CP114-10	8002556730	ITechnicalSupport@remel.com
05056080500928	Shigella boydii polyvalent 1 (1-6) Agglutinating Serum - R30163901	+4401322295600	ITechnicalSupport@remel.com
05056080501024	NA - R30165001	+4401322295600	ITechnicalSupport@remel.com

remel.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
7644	1739318087	K990842	SAS ROTA TEST	LIQ	1999-08-09
7642	2022607418	K983336	PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1	LKT	1999-03-18
7642	1906671836	K980507	PROSPECT SHIGA TOXIN MICROPLATE ASSAY	GMZ	1998-04-23
7644	1048930494	K972359	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	JSO	1997-08-28
7642	1470384874	K971663	WELLCOLEX E.COLI O157:H7	GMZ	1997-12-30
7644	1547265486	K965152	A.C.T. II	JSM	1997-01-22
7644	1754030012	K965149	A.C.T. I	JSM	1997-01-22
7644	1193463446	K964315	REMEL STAPH LATEX KIT	JWX	1997-02-07
38116	1193463446	K964315	REMEL STAPH LATEX KIT	JWX	1997-02-07
7644	1591888077	K962966	IDS RAPID CB PLUS SYSTEM	JTO	1996-10-08
38116	1591888077	K962966	IDS RAPID CB PLUS SYSTEM	JTO	1996-10-08
7642	1057423743	K962028	WELLCOLEX E-COLI OI57 ZC60	GNA	1996-11-01
7644	1969548421	K961046	10B ARGININE BROTH	JSM	1996-09-18
7644	1639941799	K960997	STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM	LIO	1996-04-03
7644	1883419476	K960313	MUELLER HINTON AGAR WITH 2% NACI	JTZ	1996-03-25
7644	1947545057	K960095	BACTIDROP CALCOFLUOR WHITE	JTS	1996-03-19
7644	1778195024	K960090	CALCOFLUOR WHITE STAIN KIT	JTS	1996-03-19
7644	1913764224	K954986	GC BASE W/ 1% GCHI	JTY	1996-02-16
7642	1216420389	K945538	STAPHAUREX PLUS(TM)	JWX	1995-06-01
7644	1881172625	K944847	KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM	JSL	1995-02-16
7644	1305576153	K943621	RAPID YEAST PLUS SYSTEM	JXB	1995-01-27
38116	1305576153	K943621	RAPID YEAST PLUS SYSTEM	JXB	1995-01-27
7644	1937591732	K943499	KULTSURE STARSWAB(M240), MODIFICATION	JSM	1994-11-30
7642	1896263531	K943317	PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV)	LKT	1994-12-19
7644	1343071083	K941579	MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)	JSM	1994-10-21
7644	1473884112	K941444	BHI AGAR WITH VANCOMYCIN	JSO	1994-09-19
7644	1240100051	K941443	SYNERGY QUAD	JSO	1994-09-19
7644	1802887496	K936021	BACTICARD STREP	JTO	1994-05-20
38116	1802887496	K936021	BACTICARD STREP	JTO	1994-05-20
7644	1133934102	K935124	BACTICARD CANDIDA	JXB	1994-02-25
38116	1133934102	K935124	BACTICARD CANDIDA	JXB	1994-02-25
7644	1490561345	K934986	BACTICARD E. COLI	JTO	1994-02-23
38116	1490561345	K934986	BACTICARD E. COLI	JTO	1994-02-23
7644	1842342920	K933457	RIM E.COLI 0157:H7 LATEX TEST	GNA	1994-04-20
38116	1842342920	K933457	RIM E.COLI 0157:H7 LATEX TEST	GNA	1994-04-20
7644	1039457320	K931383	ZINC PVA	LIO	1993-06-15
7644	1822990341	K930418	CRYPTO-LEX SYSTEM	GMD	1994-02-17
38116	1822990341	K930418	CRYPTO-LEX SYSTEM	GMD	1994-02-17
7644	1252112496	K923827	LAP DISK	JTO	1992-09-28
38116	1252112496	K923827	LAP DISK	JTO	1992-09-28
7644	1694385025	K923700	INDOXYL ACETATE DISK	JTO	1992-10-05
38116	1694385025	K923700	INDOXYL ACETATE DISK	JTO	1992-10-05
7644	1787704886	K923566	NIZYME TEST KIT	JSX	1992-11-02
38116	1787704886	K923566	NIZYME TEST KIT	JSX	1992-11-02
7644	1519682398	K921556	MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM	LJZ	1992-06-29
38116	1519682398	K921556	MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM	LJZ	1992-06-29
7644	1895999506	K921472	M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION)	JSM	1992-05-06
7644	1057729695	K920976	BACTIDROP INDIA INK	JTS	1992-06-09
7644	1136368526	K920974	BACTIDROP ACRIDINE ORANGE	JFO	1992-06-19
7644	1750056136	K920973	BACTIDROP INDOLE (ERLICH'S)	JTO	1992-06-19
7644	1253293869	K920972	BACTIDROP PYR	JTO	1992-05-22
7644	1939429602	K920971	BACTIDROP NINHYDRIN	JTO	1992-05-22
7644	1108116601	K920970	BACTIDROP KOH (10%)	JTS	1992-06-09
7644	1491758063	K920257	NIACIN CONTROL DISKS	JTO	1992-04-22
38116	1491758063	K920257	NIACIN CONTROL DISKS	JTO	1992-04-22
7642	1140740102	K915203	D-DIMER WELLCOTEST (HA10)	DAP	1992-01-31
7644	1295329819	K913011	BACTIDROP(TM) NITRATE A	JTO	1991-09-19
7644	1745363173	K913010	BACTIDROP (TM) NITRATE B	JTO	1991-09-19
7644	1061657086	K913009	BACTIDROP(TM) INDOLE (KOVACS)	JTO	1991-09-18
7644	1302713725	K913008	BACTIDROP(TM) OXIDASE	JTO	1991-09-23
7644	1452478536	K913007	BACTIDROP(TM) VOGES-PROSKAUER B	JTO	1991-09-23
7644	1236866387	K913006	BACTIDROP(TM) DOBELL & O'CONNOR IODINE	JTO	1991-09-23
7644	1713277131	K913005	BACTIDROP(TM) LACTOPHENOL ANILINE BLUE	JIO	1991-09-16
7644	1634120824	K913004	BACTIDROP(TM) SPOT INDOLE	JTO	1991-09-18
7644	1442860924	K913003	BACTIDROP(TM) VOGES-PROSKAUER A	JTO	1991-09-23
7644	1639858522	K913002	BACTIDROP(TM) FERRIC CHLORIDE (10%)	JTO	1991-09-23
7644	1953728524	K913001	BACTIDROP(TM) DESOXYCHOLATE (10%)	JTO	1991-09-18
7644	1762599827	K912832	BACTI-SWAB(TM) NPG	LIO	1991-08-22
7644	1471733840	K912831	BACTI-SWAB(TM) II	LIO	1991-07-30
7644	2050170264	K911419	SENSITITRE ARIS MODULE	LRG	1992-07-01
136165	2050170264	K911419	SENSITITRE ARIS MODULE	LRG	1992-07-01
7642	1150341581	K910797	STREPTEX ACID EXTRACTION KIT	GTZ	1991-03-29
7644	1773476268	K910526	MICROTEST MULTI MICROBE MEDIUM	JSM	1991-04-09
7644	1004469470	K910180	BACTI-SWAB	JSM	1991-05-10
7644	1142245552	K905472	LAP DISCS	JTO	1991-02-27
38116	1142245552	K905472	LAP DISCS	JTO	1991-02-27
7644	1785362809	K905163	NITRATE DISK	JTO	1991-02-20
38116	1785362809	K905163	NITRATE DISK	JTO	1991-02-20
7644	1469548910	K905151	VANCOMYCIN DISK-5 MCG	JTO	1991-01-25
38116	1469548910	K905151	VANCOMYCIN DISK-5 MCG	JTO	1991-01-25
7642	1298744846	K904167	PATHODX HERPES TYPING	GQL	1990-12-13
7644	1261725875	K902595	CATARRHALIS TEST STRIP	JTO	1990-10-02
38116	1261725875	K902595	CATARRHALIS TEST STRIP	JTO	1990-10-02
7644	1735759108	K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	1990-06-28
38116	1735759108	K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	1990-06-28
7642	1149005618	K902038	PATHO DX STREP D	GTZ	1990-05-21
7642	1524924952	K902037	PATHODX PYR KIT	JTO	1990-06-01
7642	1366088624	K900870	PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST	LJP	1990-04-16
7644	2051387085	K900517	RAPID NF SYSTEM	JSW	1990-03-13
38116	2051387085	K900517	RAPID NF SYSTEM	JSW	1990-03-13
7644	1932653453	K896347	IMMUNODOT AUTOIMMUNE SCREENING PANEL 1	LJM	1989-12-05
7642	1085514635	K895839	PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1	LJP	1990-02-01
7642	1153961041	K895461	WELLCOLEX COLOUR SHIGELLA TEST ZC51	GNB	1990-01-11
7644	1901049504	K894848	HAEMOPHILUS TEST MEDIUM (BROTH)	JSO	1989-09-06
7644	1875986622	K892928	HAEMOPHILUS TEST MEDIUM (AGAR)	JSO	1989-06-13
7644	1481852142	K891476	C. ALBICANS SCREEN	JXC	1989-04-12
38116	1481852142	K891476	C. ALBICANS SCREEN	JXC	1989-04-12
7642	1667268971	K890146	WELLCOLEX COLOUR SALMONELLA TEST ZL 50	GRM	1989-02-16
7644	1361313744	K884720	GERM TUBE SOLUTION	JXC	1989-06-02
7642	1342211402	K884026	ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT	GNA	1989-02-03
7644	1170961805	K883641	SELECTIVE RAPID UREA	LYR	1989-05-04
7644	1218986157	K882960	IDS RAPID ANA SYSTEM	JSP	1988-08-12
38116	1218986157	K882960	IDS RAPID ANA SYSTEM	JSP	1988-08-12
7644	1084749167	K882636	ALN DISCS	JTO	1989-02-16
38116	1084749167	K882636	ALN DISCS	JTO	1989-02-16
7644	1453663438	K882630	PRO DISCS	JTO	1989-02-16
38116	1453663438	K882630	PRO DISCS	JTO	1989-02-16
7644	1111379052	K881995	DIAMOND'S MEDIUM MODIFIED	KZI	1988-06-02
7644	2034310008	K881501	MODIFIED IDS RAPID NH SYSTEM	JSX	1988-05-18
38116	2034310008	K881501	MODIFIED IDS RAPID NH SYSTEM	JSX	1988-05-18
7642	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
7644	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
38116	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
7644	1781343478	K880950	PYR/ESCULIN DISK	JTO	1988-04-01
38116	1781343478	K880950	PYR/ESCULIN DISK	JTO	1988-04-01
7644	1925511247	K880717	SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR	JSJ	1988-03-03
7644	2015446776	K880716	SLIDE CULTURE PLATE-POTATO FLAKE AGAR	JSJ	1988-03-03
7644	1990038342	K872189	METHANOL, ABSOLUTE	JTS	1987-07-29
7644	1807524970	K872188	MACCONKEY W/SORBITOL	JSI	1987-06-24
7644	1504959940	K872187	TB KINYOUN CARBOLFUCHSIN	JTS	1987-07-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JTO	84	1996-10-08
JSJ	10	1988-03-03
JWY	9	2025-09-05
JSM	9	1997-01-22
JTS	9	1996-03-19
JSO	8	2017-05-01
JSS	8	1985-07-23
JSI	7	1987-06-24
LIO	6	2001-11-26
JXB	6	1995-01-27
GTZ	5	1991-03-29
KTN	5	1990-06-28
GTJ	5	1986-02-04
LRG	4	2011-09-22
GNA	4	1996-11-01
JTZ	4	1996-03-25
JSX	4	1992-11-02
JSF	4	1985-04-22
NGZ	3	2014-01-31
JWX	3	1997-02-07
JXC	3	1989-06-02
LIE	2	2011-06-22
PSZ	2	2009-08-26
MHI	2	2003-11-18
MDB	2	2003-08-22
LYR	2	2001-12-10
LKT	2	1999-03-18
GMZ	2	1998-04-23
GMD	2	1994-02-17
LJZ	2	1992-06-29
LJP	2	1990-04-16
JSW	2	1990-03-13
JSP	2	1988-08-12
HYI	2	1987-04-08
MJD	2	1984-03-23
JSN	2	1983-12-30
JTC	2	1980-07-21
DDC	2	1978-06-14
MJE	1	2007-11-26
JTW	1	2006-06-23

PMN#

Remel Spectra ESBL
2017-05-01
REMEL, INC.
REMEL XPECT FLU A&B
2013-07-12
REMEL, INC.
REMEL SPECTRA MRSA
2010-10-08
REMEL, INC.
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
2007-11-26
REMEL, INC.
XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
2004-11-15
REMEL INC
PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
2004-02-26
REMEL INC
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
2003-11-18
REMEL INC
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
2003-11-14
REMEL INC
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
2003-11-10
REMEL INC
XPECT INFLUENZA A/B
2003-07-17
REMEL INC
BACTI-SWAB DRY
2001-11-26
REMEL CO.
PAR-ONE
1998-07-14
REMEL, INC.
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
1997-08-28
REMEL, L.P.
PYR SWAB
1997-04-24
REMEL, INC.
GRAM SWAB
1997-04-17
REMEL, INC.
INDOLE SWAB
1997-04-02
REMEL, INC.
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
1997-04-02
REMEL, INC.
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
1997-04-02
REMEL, INC.
REMEL STAPH LATEX KIT
1997-02-07
REMEL, L.P.
A.C.T. I
1997-01-22
REMEL CO.
A.C.T. II
1997-01-22
REMEL CO.
A.C.T. III
1997-01-22
REMEL CO.
A.C.T. IV
1997-01-22
REMEL CO.
REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK
1996-12-06
REMEL, L.P.
10B ARGININE BROTH
1996-09-18
REMEL, L.P.
RPR LIQUID CONTROLS
1996-07-30
REMEL, L.P.
RPR CARD TEST KIT
1996-07-29
REMEL, L.P.
GENTAMICIN DISK (120MCG)
1996-07-10
REMEL, L.P.
STREPTOMYCIN DISK (300MCG)
1996-07-10
REMEL, L.P.
MUELLER HINTON AGAR WITH 2% NACI
1996-03-25
REMEL, L.P.
BACTIDROP CALCOFLUOR WHITE
1996-03-19
REMEL CO.
CALCOFLUOR WHITE STAIN KIT
1996-03-19
REMEL CO.
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
1996-02-23
REMEL CO.
GC BASE W/ 1% GCHI
1996-02-16
REMEL, L.P.
SYNERGY QUAD
1994-09-19
REMEL CO.
BHI AGAR WITH VANCOMYCIN
1994-09-19
REMEL CO.
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
1994-09-19
REMEL, INC.
BACTICARD STREP
1994-05-20
REMEL CO.
RIM E.COLI 0157:H7 LATEX TEST
1994-04-20
REMEL CO.
BACTICARD CANDIDA
1994-02-25
REMEL CO.

164 records. Showing 1-40. Next

GUDID#

ImmunoDOT Autoimmunity Panel 1 KT/100TST - R2470940
REMEL, INC.
2026-07-20
Shigella boydii polyvalent 1 (1-6) Agglutinating Serum - R30163901
REMEL EUROPE LIMITED
2026-05-05
NA - R30165001
REMEL EUROPE LIMITED
2016-12-09
NA - CP114-10
REMEL, INC.
2016-09-24
REMEL - Flagella Stain BTL/50ml
REMEL, INC.
2023-01-03
MicroTest M4RT - M4RT (3ml) no BEADS Nasal Swab Kit w/bag
Remel Inc.
2023-01-05
MicroTest M4RT - M4RT(3ml) w/o Beads PK/50
Remel Inc.
2023-01-05
R12576 M4RTUniversal Plus Swab Kit PK/100 - R12576
Remel Inc.
2024-03-29
MicroTest M6 - M6(1.5ml) Traditional FlockSwab KitPK/100
REMEL, INC.
2022-12-22
MicroTest M4RT - M4RT(3ml) Universal Flock Swab Kit PK/100
REMEL, INC.
2022-12-22
MicroTest M6 - M6 (1.5ml) Universal Swab Kit PK/100
REMEL, INC.
2022-12-22
Spectra™ Candida Agar - R01833
REMEL, INC.
2026-02-09
NA - MYCO PZA KIT
REMEL, INC.
2016-12-09
VersaTREK™ - VersaTREK™ Myco Streptomycin, 7120-30
REMEL, INC.
2025-01-16
NA - VERSATREK MYCO SUSCEPTIBILITY KIT
REMEL, INC.
2022-04-21
^BM^ PK/50 OXIDASE TEST - R9055635
REMEL, INC.
2026-01-16
Strep Selective II Agar - R01859
REMEL, INC.
2026-01-16
MicroTest - M6 (3.0ml) PK/72
Remel Inc.
2023-01-05
MicroTest M4RT - M4RT(3ml) 2NPG Swab KIT
Remel Inc.
2023-01-05
MicroTest M4RT - M4RT(3ml) Dual Swab KIT
Remel Inc.
2023-01-05
Liquid Stuarts,Wire Shaft PK/50 - R723135
REMEL, INC.
2025-06-18
Liquid Stuarts,Wire Shaft Swab PK/100 - R723130
REMEL, INC.
2025-06-18
Liquid Stuarts,Dual Swab PK/50 - R723125
REMEL, INC.
2025-06-18
Liquid Stuarts,Dual Swab PK/500 - R723120
REMEL, INC.
2025-06-18
Liquid Stuarts,Single Swab PK/50 - R723115
REMEL, INC.
2025-06-18
Liquid Stuarts,Single Swab PK/500 - R723110
REMEL, INC.
2025-06-18
Liquid Amies,Dual Swab PK/50 - R723095
REMEL, INC.
2025-06-18
Sensititre Demineralized Water - T3339
REMEL, INC.
2023-12-21
^CE^Liq Stuarts,Dual Swab 36mmPK/500 - r9723120
REMEL, INC.
2025-10-02
NA - R30165401
REMEL EUROPE LIMITED
2016-09-24
NA - R30165301
REMEL EUROPE LIMITED
2016-09-24
NA - R30164901
REMEL EUROPE LIMITED
2016-12-09
NA - R30164801
REMEL EUROPE LIMITED
2016-10-24
NA - R30163501
REMEL EUROPE LIMITED
2016-09-24
NA - R30163401
REMEL EUROPE LIMITED
2016-09-24
NA - R30163301
REMEL EUROPE LIMITED
2016-09-24
NA - R30162301
REMEL EUROPE LIMITED
2016-09-24
NA - R30161801
REMEL EUROPE LIMITED
2016-09-24
NA - R30161201
REMEL EUROPE LIMITED
2016-09-24
NA - R30161101
REMEL EUROPE LIMITED
2016-09-24

200 records. Showing 1-40. Next