CENOGENICS CORPORATION

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- Catalog Number : R-20

Device Description : Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the d Cenogenics Corporation's RF LATEX TEST KIT is a rapid latex slide test for the determination of Rheumatoid Factor in human serum.Kit Contains:5 ml RF Latex Reagent10 ml Glycine-Saline Buffer Concentrate1 ml RF Positive Control1 ml RF Negative Control6-ring slideProduct Instructions

Device Class : 2

Duns Number: 068288943

Premarket Exempt : Yes

Product Code : DHR

Prescription Use : Yes

Device Count : 1

Device Description : Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac sli Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding.The Kit Contains: 50 patient envelope kits. Each Patient Kit contains one Tri-Slide with controls and 3 applicator sticks. The envelopes are printed with easy to understand patient instructions. 3 X 10ml developing solution Product Instructions

Device Class : 2

Duns Number: 068288943

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

Device Description : Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide p Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding.The Kit Contains: 100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set. 300 applicators 6 X 10ml developing solution Product Instructions

Device Class : 2

Duns Number: 068288943

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

Device Description : Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slid Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleeding.The Kit Contains: 100 single slides. Each slide has two test areas and a positive and negative control set. 100 applicators 2 X 10ml developing solution Product Instructions

Device Class : 2

Duns Number: 068288943

Premarket Exempt : No

Product Code : KHE

Prescription Use : Yes

Device Count : 1

- Catalog Number : V-55

Device Description : VDRL Test Kit is intended for the qualitative and/or quantitative detection of n VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced in response to infection with Treponema Pallidum bacteria (syphilis). Kit contains 5.5 ml VDRL Antigen reagent, 60 ml of buffered diluent and product instructions.

Device Class : 2

Duns Number: 068288943

Premarket Exempt : Yes

Product Code : GMQ

Prescription Use : Yes

Device Count : 1

Device Description : Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-s Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide flocculation test for detection of antibodies to Treponema pallidum.The kit contains: 5ml VDRL Reactive Control Serum 5ml VDRL Weakly Reactive Control Serum 5ml VDRL Nonreactive Control Serum Product Instructions

Device Class : 2

Duns Number: 068288943

Premarket Exempt : Yes

Product Code : GMP

Prescription Use : Yes

Device Count : 1