cenogenics.netCHEMVIEW-10
CENOGENICS CORP.
CENOGENICS CORP.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2250030 | 2250030 | CENOGENICS CORP. | 1 | N | 2026-01-01 | 100 RT. 520, Drawer 308 MORGANVILLE NJ US 07751 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B224SB201 | TRI-SLIDE STOOL BLOOD TEST - 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 | (732) 536-6457 | info@cenogenics.net |
| B224SB211 | PROFESSIONAL SINGLE SLIDE KIT - 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 | (732) 536-6457 | info@cenogenics.net |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 36385 | 1587489311 | K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | JHI | 1999-08-26 |
| 36385 | 1349599039 | K894793 | MONODEX | KTN | 1989-08-21 |
| 36385 | 1055310424 | K761232 | QUICK CULT SLIDE TEST FECAL OCCULT BLOOD | KHE | 1976-12-21 |
| 36385 | 1092327511 | K042641 | CHEMVIEW-10 | JIL | 2005-01-07 |
| 36385 | 1558413093 | K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST | LCX | 2003-04-17 |
| 36385 | 1010081268 | ||||
| 36385 | 1091796982 | ||||
| 36385 | 1115837138 | ||||
| 36385 | 1350690698 | ||||
| 36385 | 1378117995 | ||||
| 36385 | 1422363527 | ||||
| 36385 | 1754117668 | ||||
| 36385 | 1820691609 | ||||
| 36385 | 1925606521 | ||||
| 36385 | 2046441825 |
Product Codes Associated With Registrations#
PMN#
ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST
CENOGENICS CORP.
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
CENOGENICS CORP.
MONODEX
CENOGENICS CORP.
URI-VAL
CENOGENICS CORP.
GUDID#
PROFESSIONAL SINGLE SLIDE KIT - 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
2021-05-27
TRI-SLIDE STOOL BLOOD TEST - 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
2021-05-27
TRI-SLIDE PATIENT ENVELOPE KIT - 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
2021-05-27
VDRL CONTROL SERUM KIT - 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
2021-05-27
RF LATEX Test Kit - 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
2021-05-27
VDRL Antigen Kit - 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.
2016-10-17