Click here for a downloadable Customer Return Checklist detailing all needed items.
Recipient & Delivery Information
Shipping Address: FamilyTreeDNA
1445 North Loop West, Suite 820
Houston, TX 77008, USA
Phone Number: +01 832-968-8312 (For courier use only)
Email Address: Shipments@genebygene.com
Contact Name (if required): Zayra Montes
Customs Declaration & Classification
Please use the following descriptions and codes exactly to ensure the package is classified as an exempt, non-hazardous research sample:
- Brief Description - "Exempt Human Specimen - Genealogy Research Only. Not a Medical Sample. No Commercial Value."
- Full Content Description - "The enclosed package consists of plastic vials containing a non-infectious, non-hazardous buffer solution and cotton swabs for genealogy testing purposes only. This package does not contain dangerous goods, drugs, medications, flammable materials, liquid nitrogen, or any animal/cell culture derived products. NOT A MEDICAL SAMPLE. Manufactured in the United States."
- Incoterms - DDP (Delivered Duty Paid)
- Requirement - All duties, taxes, and shipping fees must be paid by the sender/buyer.
- Declared Value - $1.00 USD (The DNA Sample has no commercial value).
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.
HTS Codes
NOTE: BOTH codes apply
- HS 3002.90.5250 (Exempt human specimen)
- HS 9903.01.32 (IEEPA Reciprocal Exclusion)
DNA Collection Kit (with vials)
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.
Instructions for Carrier Agent
- Verify the shipment is set to DDP (All duties/taxes paid by the shipper).
- Ensure both HTS codes are included in the digital customs filing.
- Affix the Documents Enclosed envelope (containing the Manufacturer’s Declaration and Commercial Invoice, if required) to the outside of the package.
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:
International Return Checklist
Instructions for your Shipping Carrier
Manufacturer Declaration - Kits with Vials
Manufacturer Declaration - Dry Swabs
Commercial Invoice - Kits with Vials - Available soon
Commercial Invoice - Dry Swabs
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.
Official FDA Exemption Statement
The FDA Registration and Device Listing can be found 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.
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: