Quality Microbiological, Serological and Immunological Reagents

CERTIFICATE OF ANALYSIS
The following product(s) have been manufactured in compliance with FDA'S current good manufacturing practice regulations for medical devices.

Product : hema-screen Cat. №./Product Code: HS-50

Kit Slides Developer Check Appropriate Configuration
FOR IN VITRO DIAGNOSTIC & PROFESSIONAL USE ONLY
Lot №: 0721221 Exp.: 2023-11-30
Intended Use: A rapid, qualitative method for the detection of occult blood in stool.
Slide: Matchbook type slide with guaiac-impregnated paper with on-slide positive and negative controls.
Appearance: The guaiac test strip is beige in color. There should not be any discoloration of the guaiac test strip. APPROVED
Developer: A clear solution free of any visible particles.
Contents: SLIDE: A special paper impregnated with natural guaiac resin. Contains both positive (+) and negative (-) performance
standards. The positive (+) standard contains a hemoglobin derived catalyst on the slide.
DEVELOPER: Solution containing a stabilized mixture of hydrogen peroxide (less than 6 %) and 75% denatured ethyl alcohol in aqueous
solution.
Component Quantity Lot Number Expiration Date Result
Slide N/A 50 20863 2024-04-30 Approved
Developer N/A 10 mL 20842 2023-11-30 Approved
Quality Control Criteria for Approval
When tested against a panel of human blood dilutions of known hemoglobin
Slides concentration and developed with an approved lot of developer, the guaiac Approved
paper is sensitive to 1:60,000 blood dilution with a 1+ reading.
When tested on an approved lot of hema-screen slides against a panel of
Developer human blood dilutions of known hemoglobin concentration the developer must Approved
be able to detect, the 1:60,000 blood dilution with a 1+ reading.
When tested with approved hema-screen Developer, the positive control must
Performance Positive (+) Standard turn blue upon contact.
Approved
When tested with approved hema-screen Developer, there should be no change
Performance Negative (-) Standard to the negative control.
Approved

Additional Information (Not a testing criteria)

Storage Requirements: Store at room temperature (15-30°C or 59-86°F). Do not refrigerate or freeze. Protect from heat, humidity, and light. Do not
store with volatile chemicals, e.g. iodine, chlorine (bleach), bromine or ammonia. When stored as recommended, slides will
maintain sensitivity up to three years from date of manufacture. The guaiac slides are beige in color. However, if not stored as
recommended, the slides may discolor and turn blue. Do not use after expiration date.
Certification(s): FDA Owner Operator: 2244821 ISO 13485 Certificate: FM 703584

For in vitro diagnostic use. For professional use only.

Do not substitute reagents from kits from other manufacturers. You may interchange slides & reagent from Immunostics hema-screen kits as long as the kit
components are within the expiration date. The results of the hema-screen test should be interpreted in light of other clinical and diagnostic results.

The above product has been processed in accordance with the FDA Quality System Regulations CFR 820 Title 21 & ISO 13485. It has been tested by Quality
Control and meets all final QC specifications. Each lot of hema-screen slides are tested for the established patterns of graded reactivity against a panel of human
blood diluted with known concentrations of hemoglobin. Immunostics, Inc. concludes that there is no risk to the safety, efficacy or performance of the product. This
product is released for distribution and is suitable for use as described in the technical insert until the stated expiration date.

We assure that the above product was assembled and tested according to specifications. No changes have been made to manufacturing specification, procedures, labeling, packaging, Quality
Control specifications or test methods without the prior knowledge and approval.

I certify that the above statements are true and accurate.

Signature: Date: 9/17/2021
Young-Mi Kim Rev. 05 10/2015
Quality Director

38 Industrial Way East, Ste. 1 • Eatontown, New Jersey •

07724 • T: (732) 918-0770 • F: (732) 918-0618 www.Immunostics.com