REMEL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1924669	1924669	REMEL, INC.	1	Y	2026-01-01	12076 Santa Fe Trail Dr LENEXA KS US 66215

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
00848838091827	NA - VERSATREK MYCO SUSCEPTIBILITY KIT	8002556730	csemail@thermofisher.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
7644	1048930494	K972359	REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN	JSO	1997-08-28
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
7644	1591888077	K962966	IDS RAPID CB PLUS SYSTEM	JTO	1996-10-08
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
7644	1881172625	K944847	KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM	JSL	1995-02-16
7644	1305576153	K943621	RAPID YEAST PLUS SYSTEM	JXB	1995-01-27
7644	1937591732	K943499	KULTSURE STARSWAB(M240), MODIFICATION	JSM	1994-11-30
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
7644	1133934102	K935124	BACTICARD CANDIDA	JXB	1994-02-25
7644	1490561345	K934986	BACTICARD E. COLI	JTO	1994-02-23
7644	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
7644	1252112496	K923827	LAP DISK	JTO	1992-09-28
7644	1694385025	K923700	INDOXYL ACETATE DISK	JTO	1992-10-05
7644	1787704886	K923566	NIZYME TEST KIT	JSX	1992-11-02
7644	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
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
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
7644	1785362809	K905163	NITRATE DISK	JTO	1991-02-20
7644	1469548910	K905151	VANCOMYCIN DISK-5 MCG	JTO	1991-01-25
7644	1261725875	K902595	CATARRHALIS TEST STRIP	JTO	1990-10-02
7644	1735759108	K902541	MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX	KTN	1990-06-28
7644	2051387085	K900517	RAPID NF SYSTEM	JSW	1990-03-13
7644	1932653453	K896347	IMMUNODOT AUTOIMMUNE SCREENING PANEL 1	LJM	1989-12-05
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
7644	1361313744	K884720	GERM TUBE SOLUTION	JXC	1989-06-02
7644	1170961805	K883641	SELECTIVE RAPID UREA	LYR	1989-05-04
7644	1218986157	K882960	IDS RAPID ANA SYSTEM	JSP	1988-08-12
7644	1084749167	K882636	ALN DISCS	JTO	1989-02-16
7644	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
7644	1301320098	K881247	MONO-PHILE	KTN	1988-04-07
7644	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
7644	1125260114	K872186	SULFURIC ACID 10%	JTS	1987-07-29
7644	1130916701	K872185	LIGHT GREEN	JTS	1987-07-29
7644	1537396937	K872184	TB METHYLENE BLUE	JTS	1987-07-29
7644	1911153593	K871447	TODD HEWITT W/CNA (LIM BROTH)	JSD	1987-05-13
7644	1181023245	K871286	GRAM IODINE	HYI	1987-04-08
7644	1381379123	K864205	THERMONUCLEASE AGAR W/TOLUIDINE BLUE	JSH	1986-11-24
7644	1251945191	K863216	NEIS NZY	JTO	1986-09-15
7644	1226423355	K861259	MACCONKEY W/MUG	JTO	1986-04-11
7644	1633213249	K860707	OFPBL	JSI	1986-03-11
7644	1502605154	K860302	PYR DISCS	JTO	1986-02-05
7644	1731865659	K852886	MUG DISK	JTO	1985-07-23
7644	1879282909	K852871	IDS RAPID SS/U SYSTEM	JSS	1985-07-23
7644	1181239673	K852110	IDS RAPID E PLUS SYSTEM	JSS	1985-06-04
7644	1481975892	K850291	MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS	JTZ	1985-05-10
7644	1977258277	K850194	CAFFEIC ACID DISK	JSF	1985-04-22
7644	1534378817	K844020	PYRIDOXAL DISC	JTO	1984-12-13
7644	1434181946	K844019	STREP ID TRIPLATE	JTO	1984-10-31
7644	1357193221	K843987	PYR BROTH	JTO	1984-10-30
7644	1904344628	K843194	V AGAR SELECTIVE DEEPS	JSI	1984-09-14
7644	1053932527	K843193	STREP SELECTIVE II	JSI	1984-09-14
7644	1741388555	K842297	ARGINIE BROTH	JSF	1984-06-22
7644	1947095621	K840981	NIACIN REAGENT STRIP	MJD	1984-03-23
7644	1568210464	K840890	BUFFERED CYE AGAR DEEP W/SUPPLEMENTS	JSJ	1984-03-23
7644	1930416315	K840889	CLOSTRIDIUM DIFFICILE AGAR DEEP &	JSI	1984-03-23
7644	1140951407	K840819	MICRODASE	JTO	1984-03-23
7644	1845653729	K840708	COLISTIN DISC	JTO	1984-04-13
7644	1463592343	K840686	2U PENICILLIN DISC	JTO	1984-04-13
7644	1832967875	K840685	PORPHYRIN TEST AGAR	JSF	1984-04-17
7644	1551256499	K840615	YERSINIA SUPPLEMENT	JSI	1984-03-09
7644	1158360720	K840614	RIFAMPIN DISC	JTO	1984-04-13
7644	1780698263	K840554	BLOOD AGAR W/AMPICILLIN	JSJ	1984-02-27
7644	1973873380	K840483	NOVOBIOCIN DISC	JTO	1984-03-02
7644	1656887196	K840338	HAEMOPHILUS I.D. II TRIPLATE	JSI	1984-04-17
7644	1170411554	K834066	TINSDALE ENRICHMENT	JSK	1984-01-04
7644	1560714922	K834065	A3B	JSN	1983-12-27
7644	1974312702	K834022	PVP IODINE	JTO	1983-12-30
7644	1990607698	K833968	10B	JSN	1983-12-30
7644	1756540889	K833967	CVA	JSJ	1984-01-11
7644	1668212560	K833963	HAEMOPHILUS IDENTIFICATION TEST KIT	JTO	1983-12-30
7644	2019753980	K833886	BRUCELLA AGAR	JSJ	1983-12-12
7644	1307852048	K833654	IDS RAPID STR SYSTEM	JTO	1984-02-13
7644	1246025006	K831673	OXY-SWAB	JTO	1983-06-30
7644	1285777229	K830396	UREA-PDA DISK	JSS	1983-03-08
7644	1974413936	K830323	LYSOSTAPHIN REAGENT SET	JTO	1983-02-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JTO	50	1996-10-08
JSJ	10	1988-03-03
JTS	9	1996-03-19
JSO	8	2017-05-01
JSM	8	1997-01-22
JSI	7	1987-06-24
JWY	5	2025-09-05
LIO	5	2001-11-26
JSS	4	1985-07-23
JTZ	3	1996-03-25
JXB	3	1995-01-27
JSF	3	1985-04-22
NGZ	2	2014-01-31
LRG	2	2011-09-22
PSZ	2	2009-08-26
MHI	2	2003-11-18
JSX	2	1992-11-02
KTN	2	1990-06-28
JXC	2	1989-06-02
HYI	2	1987-04-08
JSN	2	1983-12-30
LIE	1	2011-06-22
MJE	1	2007-11-26
JTW	1	2006-06-23
MJA	1	2006-01-19
LLH	1	2004-11-15
MHJ	1	2003-11-14
MDB	1	2003-08-22
GQG	1	2003-01-29
LIQ	1	1999-08-09
JWX	1	1997-02-07
JTY	1	1996-02-16
JSL	1	1995-02-16
GNA	1	1994-04-20
GMD	1	1994-02-17
LJZ	1	1992-06-29
JFO	1	1992-06-19
JIO	1	1991-09-16
JSW	1	1990-03-13
LJM	1	1989-12-05

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.
PAR-ONE
1998-07-14
REMEL, INC.
PYR SWAB
1997-04-24
REMEL, INC.
GRAM SWAB
1997-04-17
REMEL, INC.
REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
1997-04-02
REMEL, INC.
REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK
1997-04-02
REMEL, INC.
INDOLE SWAB
1997-04-02
REMEL, INC.
REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG
1994-09-19
REMEL, INC.

GUDID#

ImmunoDOT Autoimmunity Panel 1 KT/100TST - R2470940
REMEL, INC.
2026-07-20
NA - CP114-10
REMEL, INC.
2016-09-24
REMEL - Flagella Stain BTL/50ml
REMEL, INC.
2023-01-03
Spectra™ Candida Agar - R01833
REMEL, INC.
2026-02-09
MicroTest M6 - M6 (1.5ml) Universal Swab Kit PK/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) Traditional FlockSwab KitPK/100
REMEL, INC.
2022-12-22
NA - VERSATREK MYCO SUSCEPTIBILITY KIT
REMEL, INC.
2022-04-21
VersaTREK™ - VersaTREK™ Myco Streptomycin, 7120-30
REMEL, INC.
2025-01-16
NA - MYCO PZA KIT
REMEL, INC.
2016-12-09
Strep Selective II Agar - R01859
REMEL, INC.
2026-01-16
^BM^ PK/50 OXIDASE TEST - R9055635
REMEL, INC.
2026-01-16
Liquid Amies,Dual Swab PK/50 - R723095
REMEL, INC.
2025-06-18
Liquid Stuarts,Single Swab PK/500 - R723110
REMEL, INC.
2025-06-18
Liquid Stuarts,Single Swab PK/50 - R723115
REMEL, INC.
2025-06-18
Liquid Stuarts,Dual Swab PK/500 - R723120
REMEL, INC.
2025-06-18
Liquid Stuarts,Dual Swab PK/50 - R723125
REMEL, INC.
2025-06-18
Liquid Stuarts,Wire Shaft Swab PK/100 - R723130
REMEL, INC.
2025-06-18
Liquid Stuarts,Wire Shaft PK/50 - R723135
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
BactiSwab Dry PK/100 - R723135
REMEL, INC.
2025-06-19
Amies Clear Gel,Single Swab PK/500 - R723000
REMEL, INC.
2025-06-18
Amies Clear Gel,Single Swab PK/50 - R723005
REMEL, INC.
2025-06-18
Amies Clear Gel,Dual Swab PK/500 - R723010
REMEL, INC.
2025-06-18
Amies Clear Gel,Dual Swab PK/50 - R723015
REMEL, INC.
2025-06-18
Amies Clear Gel,Wire Shaft Swab PK/100 - R723020
REMEL, INC.
2025-06-18
Amies Clear Gel,Wire Shaft PK/50 - R723025
REMEL, INC.
2025-06-18
Amies Charcoal Gel,Single Swab PK/50 - R723045
REMEL, INC.
2025-06-18
RapID - RapID STAPH PLUS QC Set/4
REMEL, INC.
2022-12-23
REMEL - Anaer Nitrate Reagent A BTL/25ml
REMEL, INC.
2023-01-03
REMEL - Bile Solubility Reagent (2%) BTL/25ml
REMEL, INC.
2023-01-03
REMEL - Anaer Nitrate Reagent B BTL/25ml
REMEL, INC.
2023-01-03
REMEL - Nitrate Reagent A for AFB BTL/25ml
REMEL, INC.
2023-01-03
REMEL - Nitrate Reagent B for AFB BTL/25ml
REMEL, INC.
2023-01-03
REMEL - PS80 Hydrolysis Substrate Conc VL/5ml
REMEL, INC.
2022-12-27
REMEL - Malachite Green (5%) BTL/250ml
REMEL, INC.
2023-01-03
REMEL - R21262 Sodium Citrate (2.94%) BTL/250ml
REMEL, INC.
2023-01-04
REMEL - TB Digestant (4% NaOH) BTL/250ml
REMEL, INC.
2023-01-04
REMEL - R21270 R21270 TB Base Digestant BTL/100ml
REMEL, INC.
2023-01-04

200 records. Showing 1-40. Next