Sole Source letter.pdf

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Attached to
BAC Somatic
Solicitation number
55AGR-S3671
Issued by
Nevada

About this file

This is a sole source justification letter from FOSS North America submitted to the Nevada Department of Agriculture in support of a procurement for an integrated bacteria and somatic cell count tester. The letter, dated August 21, 2025, establishes that FOSS North America is the exclusive manufacturer and distributor of the BacSomatic™, a specialized laboratory instrument designed to measure bacterial and somatic cell counts in raw cow milk samples. The BacSomatic™ utilizes flow cytometry technology with automated sample processing capabilities, offering analysis times of 9.5 minutes for integrated bacterial counts and 1.5 minutes for somatic cell counts, with processing capacities ranging from 15 to 40 samples per hour depending on the analysis type. The instrument features a reagent bag system for contact-free reagent use and accommodates various sample intake volumes based on the analysis being performed.

The BacSomatic™ holds multiple regulatory approvals including EURL/Microval, FDA/NCIMS, and compliance with ISO/IDF standards, supporting the sole source justification. The measuring range for integrated bacterial counts spans 5,000 to 20 million IBC/mL with a performance range of 10,000 to 10 million IBC/mL, while somatic cell counts range from 0 to 10 million cells/mL with a performance range of 100,000 to 1.5 million cells/mL. As the exclusive manufacturer and distributor of this unique and proprietary technology, FOSS North America positions itself as the only qualified vendor capable of meeting the Nevada Department of Agriculture's specific procurement requirements.

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Text version

FOSS

North America 6509 Flying Cloud Dr. Suite 130 Eden Prairie, MN 55344

Phone +1 952-974-9892 Fax +1 952-974-9823 E-mail info@fossna.com Web www.fossanalytics.com

Sole Source: BacSomatic

Date: August 21, 2025

Subject: Sole Source Justification for Purchase of the BacSomaticTM

To whom it may concern, I am writing to inform you that Foss North America is the exclusive manufacturer and distributor of the BacSomaticTM. We take pride in our ability to provide this unique and innovative instrument, which have been developed and refined through our extensive research and development efforts.

The BacSomaticTM is the first-ever integrated bacteria and somatic cell tester that offers full auto-mation for minimal reagent handling and consistent test results. These unique characteristics in-clude:

Flow Cytometry Technology: Both bacteria and somatic cell counts use flow cytometry, where stained cells pass a laser and emit fluorescent signals that are counted and displayed in a PHA diagram.

Integrated Bacteria Somatic Cell Count: The flow system directs samples to either a bac-teria incubator or somatic cell mixing chamber, where cells are stained and measured with laser light at different intensities. Both counts can be done simultaneously or separately.

Reagent Bag System: Reagents are provided ready-to-use bags for contact free use.

Sample Types: Raw cow milk Analysis Time: 9.5 minutes for IBC, 1.5 minutes SCC Analysis Capacity:

o SCC and IBC: 15 samples/hour o IBC Only: 15 samples/hour o SCC Only: 40 samples/hour

Sample Intake:

o SCC and IBC: 7.2 mL o IBC: 6.4 mL o SCC: 2.5 mL

Measuring Range:

o IBC: 5,000-20 mill. IBC/mL (approx. 1,500 to 10 mill CFU/ml) o SCC: 0-10 mill. cells/ml

Performance Range:

o IBC: 10,000 - 10 mill. IBC/mL o SCC: 100,000 - 1.5 mill. cells/mL

Application Notes: detailed application notes describe the method and the performance of the application.

Approvals:

o EURL/Microval o FDA/NCIMS o In compliance with ISO/IDF standards

Thank you for considering Foss North America as your partner in achieving excellence. Please do not hesitate to contact me directly at tvesey@fossna.com if you have any questions or require further information.

Sincerely, Taylor Vesey Laboratory Industry Sales Manager TVesey@FossNA.com

(469) 560-2114

File details come from the government source that posted it. Updated .