TRI-SLIDE PATIENT ENVELOPE KIT SB-19

GUDID B224SB191

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

CENOGENICS CORPORATION

Faecal occult blood IVD, kit, chromogenic, rapid

• Primary Device ID: B224SB191
• NIH Device Record Key: 5fa17a9e-6b49-4f7f-ad10-5f3088f87e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRI-SLIDE PATIENT ENVELOPE KIT
• Version Model Number: SB-19
• Catalog Number: SB-19
• Company DUNS: 068288943
• Company Name: CENOGENICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B224SB191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K761232

FDA Product Code

• KHE: Reagent, Occult Blood

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-04
• Device Publish Date: 2021-05-27

Devices Manufactured by CENOGENICS CORPORATION

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• B224SB191 - TRI-SLIDE PATIENT ENVELOPE KIT: 2021-06-04Cenogenics 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
• B224SB191 - TRI-SLIDE PATIENT ENVELOPE KIT: 2021-06-04 Cenogenics Corporation's TRI-SLIDE PATIENT ENVELOPE KIT is a six test guaiac slide procedure to effectively screen for intermitt
• B224SB201 - TRI-SLIDE STOOL BLOOD TEST: 2021-06-04 Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent
• B224SB211 - PROFESSIONAL SINGLE SLIDE KIT: 2021-06-04 Cenogenics Corporation's PROFESSIONAL SINGLE SLIDE KIT is a two test guaiac slide procedure to screen for gastrointestinal bleed
• B224V611 - VDRL CONTROL SERUM KIT: 2021-06-04 Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide
• B224V551 - VDRL Antigen Kit: 2018-03-29 VDRL Test Kit is intended for the qualitative and/or quantitative detection of non-specific reagin antibodies that are produced