Wharton’s jelly is a connective tissue located within the umbilical cord largely composed of extracellular matrix components, including collagen, chondroitin sulfate, hyaluronic acid, and sulfated proteoglycans. Wharton’s jelly is a promising and applicable biologic source for regenerative applications.

According to FDA’s 21 CFR § 1271.3, homologous use means the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.

Under the Public Health Service Act (PHSA) and implementing regulations, the FDA regulates HCT/Ps. The HCT/P regulations require manufacturers to register their products, create donor eligibility criteria, and establish procedures, such as current good tissue practices (cGTPs), to prevent the spread of communicable diseases.

Products that fall under Section 351 are regulated similarly to drugs or devices which must have an Investigational New Drug Application (IND) in effect or acquire pre-market approval to be commercially marketed. Section 361 governs HCT/Ps that meet the criteria listed in 21CFR 1271.10(a). Products that fall under section 361 do not need an IND or premarket approval to be distributed because if they retain their primary functions for homologous use, they are considered a known quantity and thus would not warrant further investigation.

For structural tissue, minimal manipulation means that the processing of the HCT/P does not alter the original relevant characteristics of the tissue relating to the tissue's utility for reconstruction, repair, or replacement.

We give you the ability to use as much as you want or as little as you want. You can aliquot the volumes you need per day and keep the rest frozen. Only expiration date is the one-year manufacturing date.

• We offer “Prefilled Plate” options = (96 Well Plate) & (384 Well Plate)
• Our Protocols are Simple and Robust; No complicated formula to create the Master Mix.
• Our Assays were designed to hit all the major pathogens for maximum info to clinician and to achieve max reimbursement for client.

All our Assays are Greater than 98% Sensitivity and Specificity leading to greatly reduced risk of False Positives and Negatives

Yes! During the research and development phase, we run our tests thousands of times in real world usage to ensure the highest quality of assay and pathogen detection.

As a High Complexity Lab, you are given the privilege of running LDT’s (Laboratory Derived/Developed Tests). An LDT is created via Validation Rules set out by the local CLIA and State agencies for LDT adoption. We offer Validation Services!

At MTG, we strive to offer high quality products in all of the heavy hitting categories to satisfy clinicians and their need for the patients diagnosis. We stand by our products even after we sell it to you. We are a medium sized company that is directly in contact with you and we strive to offer fast response to any inquiries or requests you might have!

If you have an Open Channel Machine, which means it can accept Third Party Reagents, then it will accept our assays! We use fluorophores common amongst all machines but should be checked with client.

Depending on whether its Bacterial DNA or Viral RNA … an Extraction method is needed to Purify the Sample RNA or DNA. This is applicable to all of our products other than covid direct which is Extractionless. The lab might already have an extraction method -> if the method is an extraction machine, our 192 extractor Can Do 1-192 Specimens in about 12-15 Minutes for both RNA and DNA with our plate kit. If extraction is manual, we can increase throughput and decrease mistakes done by human error (Blood/Stool lysis extraction kits release TBD)

For All Assays We Offer = (100 Kit Sizes) (Liquid) 96 well) (Prefilled Plate) (384 well) (Prefilled Plate)

No special Labware is needed outside what is already in a Molecular Diagnostics Lab.