SERIM RESEARCH CORPORATION

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Helicobacter Pylori (LYR) (2) Sterilant, Medical Devices (MED) (1) Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (MSY) (1) Test, Urine Leukocyte (LJX) (1)

Premarket Exempt

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Serim® PeriScreen™ Test Strips - M17451221 Catalog Number : 5122

Device Description : Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood ce Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.

Device Class :

Duns Number: 605151018

Premarket Exempt : No

Product Code : LJX

Prescription Use : No

Device Count : 10

Serim® DISINTEK™ GTA 1.5% Test Strips - M1745136A1 Catalog Number : 5136A

Device Description : Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaralde 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.

Device Class :

Duns Number: 605151018

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 50

Serim® PyloriTek® Test Kit - M1745140K1 Catalog Number : 05140K

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

Device Class :

Duns Number: 605151018

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 20

Serim® PyloriTek® Test Kit - M1745140S1 Catalog Number : 05140S

Device Class :

Duns Number: 605151018

Premarket Exempt : No

Product Code : LYR

Prescription Use : No

Device Count : 5

Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips - M17451671 Catalog Number : 5167

Device Description : SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlor 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.

Device Class :

Duns Number: 605151018

Premarket Exempt : No

Product Code : MSY

Prescription Use : No

Device Count : 100

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