SERIM RESEARCH CORP.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1833387	1833387	SERIM RESEARCH CORP.	1	N	2026-01-01	3506 Reedy Dr ELKHART IN US 46514

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
M17451061	Serim® GUARDIAN™ Peracetic Acid Test Strips - SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.	800-542-4670	customerservice@serim.com
M17451092	Serim® GUARDIAN™ HiSENSE™ Test Kit - The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.	800-542-4670	customerservice@serim.com
M1745116A1	Serim® GUARDIAN™ Bicarb pH II Test Strips - Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.	800-542-4670	customerservice@serim.com

serim.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
12088	1495385627	K953632	SERIM PYLORITEK TEST KIT	LYR	1995-12-18
12088	1168168434	K952215	SERIM HISENSE TEST KIT	FIP	1995-08-09
12088	1501580540	K945491	SERIM(TM) BICARB PH REAGENT STRIPS	MNV	1995-02-01
12088	1605647367	K914123	SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS	LIF	1992-04-09
12088	1294944480	K913943	SERIM DISINTEK REAGENT STRIPS	MED	1992-03-26
12088	1679497856	K910320	SERIM PERACETIC ACID REAGENT STRIPS	JOJ	1991-05-01
12088	1419632196	K901734	SERIM RESIDUAL CHLORINE TEST KIT	FKJ	1990-09-13
12088	1853380757	K900341	SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT	LIF	1990-07-11
12088	1114913146	K120652	RAPICIDE OPA-28 TEST STRIP	JOJ	2012-10-12
12088	1579012393	K082352	SERIM DISINTEK OPA TEST STRIP	JOJ	2008-09-25
12088	2053531576	K081370	SERIM DISINTEK OPA TEST STRIP	JOJ	2008-07-11
12088	1217442953	K080712	SERIM HISENSE ULTRA 0.1, PART NUMBER 5167	MSY	2008-05-06
12088	1871992185	K012115	SERIM BLOOD LEAK TEST STRIP-2	FJD	2001-11-30
12088	1667447889	K000578	SERIM LEUKOCYTE ESTERASE TEST STRIPS	LJX	2000-05-05
12088	1318400817

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
JOJ	4	2012-10-12
LIF	2	1992-04-09
MSY	1	2008-05-06
FJD	1	2001-11-30
LJX	1	2000-05-05
LYR	1	1995-12-18
FIP	1	1995-08-09
MNV	1	1995-02-01
MED	1	1992-03-26
FKJ	1	1990-09-13

PMN#

WAVICIDE-OPA MEC Indicator

2020-12-02

Serim Research Corporation

QwikCheck Chemical Indicators

2020-04-02

Serim Research Corporation

RAPICIDE OPA-28 TEST STRIP

2012-10-12

SERIM RESEARCH CORP.

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171

2010-01-07

SERIM RESEARCH CORP.

SERIM DISINTEK GTA 2.1%, MODEL: 5164

2009-03-16

SERIM RESEARCH CORP.

SERIM DISINTEK OPA TEST STRIP

2008-09-25

SERIM RESEARCH CORP.

SERIM DISINTEK OPA TEST STRIP

2008-07-11

SERIM RESEARCH CORP.

SERIM HISENSE ULTRA 0.1, PART NUMBER 5167

2008-05-06

SERIM RESEARCH CORP.

SERIM PERACETIC ACID CHEMICAL INDICATOR

2005-12-01

SERIM RESEARCH CORP.

SERIM DIALYSATE MONITOR TEST STRIP

2005-06-13

SERIM RESEARCH CORP.

PYLORITEK VP TEST KIT 5140VP

2002-02-08

SERIM RESEARCH CORP.

SERIM BLOOD LEAK TEST STRIP-2

2001-11-30

SERIM RESEARCH CORP.

SERIM LEUKOCYTE ESTERASE TEST STRIPS

2000-05-05

SERIM RESEARCH CORP.

CIDEX OPA SOLUTION TEST STRIP

1999-11-23

SERIM RESEARCH CORP.

SERIM BLOOD LEAK TEST STRIP

1999-04-21

SERIM RESEARCH CORP.

SPOROX TEST STRIPS

1997-08-29

SERIM RESEARCH CORP.

SERIM PYLORITEK TEST KIT

1995-12-18

SERIM RESEARCH CORP.

SERIM HISENSE TEST KIT

1995-08-09

SERIM RESEARCH CORP.

SERIM(TM) BICARB PH REAGENT STRIPS

1995-02-01

SERIM RESEARCH CORP.

WAVICIDE MONITOR STRIPS

1994-06-02

SERIM RESEARCH CORP.

SERIM PYLORITEK REAGENT STRIPS

1994-04-21

SERIM RESEARCH CORP.

SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS

1992-04-09

SERIM RESEARCH CORP.

SERIM DISINTEK REAGENT STRIPS

1992-03-26

SERIM RESEARCH CORP.

SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)

1991-06-27

SERIM RESEARCH CORP.

SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)

1991-06-27

SERIM RESEARCH CORP.

SERIM PERACETIC ACID REAGENT STRIPS

1991-05-01

SERIM RESEARCH CORP.

SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT

1991-04-02

SERIM RESEARCH CORP.

SERIM RESIDUAL CHLORINE TEST KIT

1990-09-13

SERIM RESEARCH CORP.

SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT

1990-07-11

SERIM RESEARCH CORP.

GUDID#

Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips - 5212

SERIM RESEARCH CORPORATION

2026-03-30

Serim® PeriScreen™ Test Strips - Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Peracetic Acid Test Strips - SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Bicarb pH II Test Strips - Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® DISINTEK™ GTA 1.5% Test Strips - Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Minimum Effective Concentration (MEC) of 1.5% for CIDEX® or MetriCide® reusable glutaraldehyde high-level disinfectants.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® DISINTEK™ OPA Test Strips - Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.

SERIM RESEARCH CORPORATION

2017-02-12

Serim® GUARDIAN™ HiSENSE™ Test Kit - The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® GUARDIAN™ Residual Peroxide Test Strips - Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

2016-08-29

Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips - SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® DISINTEK™ OPA Test Strips - Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalaldehyde, the active ingredient in CIDEX® OPA Solution and MetriCide® OPA Plus™ Solution, is above or below the established minimum effective concentration (MEC) of 0.3%.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during thehemodialysis procedure.

SERIM RESEARCH CORPORATION

2017-02-12

Serim® GUARDIAN™ HiSENSE™ Test Kit - The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® GUARDIAN™ Residual Peroxide Test Strips - Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyzers after disinfection with peracetic acid/peroxide-based disinfectants.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.

SERIM RESEARCH CORPORATION

2026-01-29

Serim® GUARDIAN™ Residual Formaldehyde Test Strips - Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® GUARDIAN™ Blood Leak Test Strips - Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during thehemodialysis procedure.

SERIM RESEARCH CORPORATION

2026-01-29

Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips - SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

2016-09-08

Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

2016-08-29

Serim® PyloriTek® Test Kit - The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori.

SERIM RESEARCH CORPORATION

2016-09-19

Serim® GUARDIAN™ Residual Chlorine Test Strips - Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

2016-08-29

Serim® GUARDIAN™ - Serim® GUARDIAN™ BICARB pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.

SERIM RESEARCH CORPORATION

2016-08-29