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At-Home & Direct-to-Patient Test Providers

End-to-end kitting and fulfillment for fertility, genomics, chronic disease, and wellness testing, with seamless return logistics. 

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Custom & Compliant Kit Fulfillment for Healthcare

Section Overview

WellPact, an FDA-Registered Re-packager & Re-labeler of medical devices and supplies, serves as an outsourced  operations engine, seamlessly managing the complexities of:

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561910:

 Packaging &
Labeling Services

541614:

Process, Physical Distribution, & Logistics  Consulting Services

493110:

General Warehousing & Storage

493190:

Other Warehousing & Storage

561499:

All Other Business Support
Services

323111:

Commercial
Printing

NAICS Codes

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PSC Codes 

R408 | R499 | R604 | R706 | R799 | S215 | T099

Registrations

  • SAM Unique Entity Identifier (UEI): E51LZM71N966

  • CAGE Code: 9WUE0

  • FDA Registration: 3030896267

Certifications

  • SBA Women-Owned Small Business (WOSB)

  • WBENC Women’s Business Enterprise (WBE)

  • ISO 13485:2016 - Quality Management System for medical devices

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Partnering for Innovation & Impact

WellPact’s Operational Space

WellPact is a trusted operational partner for Prime Contractors and Government Agencies, powering health through scalable, compliant, and seamless custom kit
assembly and fulfillment solutions for healthcare, diagnostics, and life sciences programs.

As an FDA-registered, ISO 13485-certified provider, we deliver precision,  compliance, and reliability. From advancing healthcare delivery to supporting public health initiatives and emergency response efforts, we help you make a meaningful impact on the communities you serve—one well-packaged kit
at a time. 

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Scalable Emergency Response 

Advancing Healthcare for Veterans & Military

Focus on Health Equity and Access

Customized Public Health
Campaign Kits

End-to-End Fulfillment Services 

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Customizable Branding and Packaging 

Sourcing and Procurement 

Kitting and Fulfillment

Individual Kit Barcoding &Tracking

Lot & Expiration Date Tracking

Ensuring Compliance, Accuracy, & Complete Traceability 

Why Tracking, Serialization, and Compliance Matter for Your Business

 

In healthcare, accuracy isn’t just important—it’s critical. Every kit, test, and medical component must be accounted for to ensure patient safety, regulatory compliance, and operational efficiency. That’s why WellPact has built a system that tracks every piece of a kit from the moment it’s assembled to when it reaches the patient and beyond. 

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National Institutes of Health
(NIH)

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Center for Disease Control &
Prevention (CDC)

Substance Abuse & Mental Health Services Administration
(SAMHSA)

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Health Resources & Services
Administration (HRSA)

DoD Military Health System
(MHS)

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Administration for Strategic
Preparedness & Response
(ASPR)

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Indian Health Services
(IHS)

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Indian Health Services
(IHS)

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Lot Tracking & Expiration Management

ThisEvery medical component has an expiration date. If outdated materials get used in a test, the results may be unreliable or even dangerous. Our system tracks expiration dates and ensures only valid, high-quality components are used. 

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Barcode & Serial Number Integration

Each kit and its components are assigned unique serial numbers and barcodes. This means if there’s ever an issue—like a recall on a swab or reagent—we can pinpoint exactly which kits contain the affected component and take immediate action. 

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Full Visibility & Recall Readiness

If a supplier issues a recall, you need to act fast. With WellPact, you’ll know exactly which kits are impacted, where they are, and who received them—eliminating guesswork and protecting patients. 

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Patient-Level Tracking

Our system links shipping details, test taker ID, and barcode data together. This ensures that every test result is tied to the correct patient, reducing errors and ensuring compliance with regulatory requirements. 

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ISO 13485 & FDA Compliance

Meeting regulatory standards isn’t optional. Our processes are built to comply with ISO 13485 (the international standard for medical device quality management) and FDA regulations, ensuring that every kit meets the highest standards for safety and reliability. 

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Why Specialization in Healthcare Fulfillment Matters

As an FDA-registered, ISO 13485-certified provider, we deliver precision, compliance, and reliability. From advancing healthcare delivery to supporting public health initiatives and emergency response efforts, we help you make a meaningful impact on the communities you serve—one well-packaged kit at a time.

  • Tailored solutions for specimen self-collection kits,
    diagnostic kits, healthcare kits, and medical supply
    kits, meeting precise program needs.

  • Streamlined sourcing of medical-grade components, packaging, and materials to ensure compliant, reliable, and cost-effective supply chains.

  • Flexible solutions from small-batch pilots to high volume national deployments, including direct-to-patient and provider fulfillment

  • Barcoding, tracking, and scanning ensure complete traceability of every kit and specific components, with real-time operational insights.

  • FDA-registered, ISO 13485-certified, and HIPAA compliant workflows ensuring full regulatory compliance and audit readiness.

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Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

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Comprehensive Health Panels, Standard Health Panels, Annual Health Panels, Whole Health Testing, Combination Testing

Comprehensive Health Panels

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

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Fertility Testing, HCG Urine, Luteinizing Hormone (LH), Menopause, Men's Fertility, Men's Health, Pregnancy, Pregnanediol Glucuronide, Progesterone, Women's Health

Reproductive Health & Fertility Testing

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

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Chlamydia STI, Colon Cancer, Covid-19, Crypto Giardia, Early Detection Cancer Screening, Fecal Occult Blood, Hepatitis B, HIV, H. Pylori, Influenza A & B, Measles, MMR Immunity, Mono, RPR Syphilis, Rubella, SARS-CoV-2, Staph, Strep, Tuberculosis

Infectious Disease & Cancer Screening

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

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Common Allergy Testing, Food Sensitivity Testing, Chemical Sensitivity Testing, Environmental Factor / Intolerance Testing

Allergy & Food Sensitivity Testing

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Anemia, B12/Folate, Blood Biomarkers, Blood Type, Cholesterol Lipid Panel, Complete Blood Testing, Glucose, Inflammation Biomarkers, Liver Health, Metabolic Panel, Rheumatoid Factor, Thyroid Stimulating Hormone (TSH), Vitamin Levels, Vitamin Methylation

General Health &
Blood Tests

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Why Choose WellPact

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Products Designed For You

Custom Kit Assembly & Packaging

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