Products

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EV-PURE+

Minimally manipulated, bio-ethical human umbilical cord harvested product manufactured under the AATB and FDA HCT/P 361 guidelines

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WJ-PURE+

Minimally manipulated, bio-ethical human umbilical cord harvested product manufactured under the AATB and FDA HCT/P 361 guidelines

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NS-PURE

Minimally manipulated, bio-ethical human umbilical cord harvested product manufactured under the AATB and FDA HCT/P 361 guidelines

EV-OPTI
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Lubricating eye drops. Minimally manipulated, bio-ethical human placenta harvested product manufactured under the AATB and FDA HCT/P 361 guidelines.

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Testing & Validation

20% of every lot manufactured is sent for sterility and endotoxin testing by a 3rd party C.L.I.A. Certified laboratory.  In addition, Vitti Labs requires a TRPS Report for each lot and a biannual Characterization Report produced by internal and external laboratories for transparency and validation.

 

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EV-PURE+

 

EV-PURE+ is a minimally manipulated, bio-ethical human umbilical cord harvested product manufactured under the AATB and FDA HCT/P 361 guidelines.

EV-PURE+ Product Options

 

EV-PURE+ 15 Billion - 1mL

EV-PURE+ 75 Billion - 4.5 mL

*Packaging may be different than illustrated

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REGULATIONS

 

Vitti Labs is an FDA registered Tissue Bank which means they implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, Vitti Labs implements AATB standards, follows GMP guidelines, and only works with tissue procurement organizations within the United States that follow AATB requirements.

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WJ-PURE+

 

WJ-PURE+ is a minimally manipulated, bio-ethical human umbilical cord harvested product manufactured under the AATB and FDA HCT/P 361 guidelines.

WJ-PURE+ Product Option

WJ-PURE+ 1mL

*Packaging may be different than illustrated

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REGULATIONS

 

Vitti Labs’ WJ-PURE+ contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function. WJ-PURE+ does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.

 

Vitti Labs is an FDA registered Tissue Bank which means they implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, Vitti Labs implements AATB standards, follows GMP guidelines, and only works with tissue procurement organizations within the United States that follow AATB requirements.

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NS-PURE
TOPICAL
NS-PURE is a minimally manipulated, bio-ethical human placenta harvested product manufactured under the AATB and FDA HCT/P 361 guidelines.
NS-PURE Product Options

NS-PURE 1.5mL

NS-PURE 4.5mL

*Packaging may be different than illustrated

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REGULATIONS

 

Vitti Labs’ NS-PURE contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function.  NS-PURE does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.

 

Vitti Labs is an FDA registered Tissue Bank which means they implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, Vitti Labs implements AATB standards, follows GMP guidelines, and only works with tissue procurement organizations within the United States that follow AATB requirements.

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EV-OPTI
LUBRICATING EYE DROPS

EV-OPTI Drops is a minimally manipulated, bio-ethical human placenta harvested product manufactured under the AATB and FDA HCT/P 361 guidelines.

EV-OPTI Product Option

EV-OPTI 0.25mL - 30 Day Supply

*Packaging may be different than illustrated

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REGULATIONS

 

Vitti Labs’ EV-OPTI contains live cells but does not claim that it is dependent on the metabolic activity of living cells for its primary function.  EV-OPTI does meet the criteria under 1271.3(d) as an HCT/P, and therefore is regulated under 21 CFR 1271 and Section 361 of the PHS Act.

 

Vitti Labs is an FDA registered Tissue Bank which means they implement and maintain FDA regulations, prioritize legal council and perform regular internal audits. Additionally, Vitti Labs implements AATB standards, follows GMP guidelines, and only works with tissue procurement organizations within the United States that follow AATB requirements.

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Values and Practices

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 Sourcing

Vitti Labs only accepts bio-ethically donated birth tissue from healthy consenting mothers who have passed a comprehensive medical background check, blood screenings, and are full-term, live, C-section births in the United States. In addition, Vitti Labs only works with tissue procurement organizations within the United States who use collection techniques that follow the AATB guidelines, prioritizing the health and safety of the mother and baby above procurement. Vitti Labs does this to strive to have a 100% FDA and AATB compliant supply chain, validated sterility, and the highest quality procurement.