International Return Shipping

Our DNA collection kits contain a return mailing envelope with the address for our lab printed on it. If your return mailing envelope is lost or damaged you may mail the sample directly to us at:

FamilyTreeDNA
1445 North Loop West, Suite 820
Houston, TX 77008
Phone #: 01-832-968-8312* 

*Courier use only, not for customer inquiries

DNA Processing Consent Form Requirements

There are several key points to remember when mailing your completed DNA sample to us.

• The DNA Processing Consent Form must be included along with your DNA Sample. If the DNA Processing Consent Form is missing from your kit or damaged, a new one can be downloaded and printed here.
• The name of the DNA donor on the Processing Consent Form must match the name on the kit.
• Minors under the age of 13 cannot be DNA tested regardless of parental consent due to international privacy laws, so the month and year of birth on the form is required.
• You cannot re-label collection kits with a kit number different from the one that is printed on the label for that collection kit. If you have lost or damaged your kit, Customer Service will be happy to assist in getting a replacement sent to you.

IMPORTANT: The DNA Processing Consent Form must contain the name, DOB, genetic sex, and signature of the DNA donor, regardless of the person who purchased the test. The name of the tester MUST be on the correct line, so read carefully.

Regulatory Forms

You can download the Lysis Buffer Vials Regulatory Letter, Dry Swabs Regulatory Letter, or courier details for return shipping by clicking one of the following:

Lysis buffer GxG Regulatory Letter for Customs

Dry Swabs GXG Regulatory Letter for Customs

Returning Your Kit to FamilyTreeDNA
 

Tariffs, duties, and Harmonized Tariff Schedule (HTS) Codes

All duties and taxes for shipments being returned to the U.S. for processing are the customer's responsibility. HTS codes are subject to change at any time, depending on your location, so it is important to check before mailing any parcels to our U.S. lab. 

DNA Collection Kit 

This kit contains vials and the lysis buffer solution for collecting a saliva sample.

The liquid contents of the lysis buffer, including Tris HCL, SDS, and NaCl, are existing chemical substances that are already on the TSCA Inventory as exempt.

Dry Swabs

Some countries require dry swab collection kits. This kit contains only dry swabs for sample collection. These do not include vials or lysis buffer.

NOTE: Collection kit components country of origin is the United States.

IMPORTANT: For U.S. exports being returned to the U.S. unimproved, the HTS code is 9801.00.10.

• This special provision allows for duty-free re-entry of goods.
• This code should be used when contents are being returned to the U.S. and have NOT been advanced in value or improved in condition by any process of manufacture while abroad.

Customs Declaration for Returning Kits

The following information is for customers to give to Customs or Postal Services when returning their kit:

What if my carrier asks for just one code?

Some international shipping systems may list a single code or may prioritize the exemption code.

• It is OK if your local carrier insists on using 9903.01.32 as the primary code instead of one of the two primary codes.
• You must ensure the Description of Goods is written as: "Exempt Human Specimen - Buccal Swab - Research Only. No Commercial Value. Non-Infectious - FDA IUC 180.000”

Official FDA Exemption Statement

The following statement can be accessed here. 

The item in this shipment is a NucleoShield Specimen Collection Container, manufactured in the United States by Gene by Gene. It is being returned to the U.S. manufacturer for testing. This item is a Class I Medical Device that is EXEMPT from FDA Premarket Notification (510k). It does not require a specific 510(k) number for import.

FDA Registration Details

• Manufacturer: Gene by Gene (Houston, TX, USA)
• FDA Establishment Registration #: 3007261225
• Device Proprietary Name: NucleoShield
• Classification Name: Container, Specimen Mailer and Storage, Non-Sterile
• Regulation Number: 864.3250
• Product Code: NNK
• Submission Type: 510(k) EXEMPT

Verification

This status can be verified in the U.S. Food & Drug Administration's Establishment Registration & Device Listing database.

Why is this exempt?

The U.S. FDA classifies this type of specimen container (Product Code NNK) as a Class I device. Class I devices are low-risk items that are generally exempt from the rigorous "Premarket Notification" process (510k) that applies to complex medical equipment.

You do not need a specific license number to ship this back to the USA. The Registration Number (3007261225) and Regulation Number (864.3250) provided above are sufficient for customs clearance.

Countries That Require Special Handling When Returning Kits

We are aware that in some (or all) cases the following countries will, at least part of the time, require special handling when customers return kits:

• Brazil
• Japan
• Mexico
• Saudi Arabia

Replacement Kits 

When a replacement kit is ordered, there is a chance that the original DNA collection kit sent to you was delayed rather than lost. In such cases, when you receive the replacement kit, it is crucial not to use it for any other individual. Submitting samples from different individuals under the same kit number can cause significant delays in testing.

Regulatory Forms

You can download the Lysis Buffer Vials, Dry Swabs Regulatory Letter, or courier details for return shipping by clicking one of the following: