FOR FERTILITY CLINICS, EGG DONOR AGENCIES & SPERM BANKS
FDA donor eligibility testing for egg and sperm donors
Kits to your clinic. Results from our lab.
Order FDA donor eligibility kits for your egg and sperm donors. Kits are delivered to your clinic or provider for a trained professional to collect the venous blood draw (plus a urine specimen for chlamydia and gonorrhea). Every test runs in IHDLab's own CLIA-certified, FDA-registered laboratory in Irvine, California, with results in 24 to 72 hours from receipt of sample. IHDLab works only with clinics, agencies and banks.
CLIA Certified Lab
#05D2040304
FDA Registered Facility
#FEI3011213917
CA Lab License
CLF00342268 · NY and MD licensed
HIPAA-compliant
results portal
COMPLIANCE FILE
Download our FDA donor binder
Get the complete FDA donor binder for your compliance file. Enter your email and we will send the download link.
Why IHDLab
Donor testing that stays in-house, from kit to result
Run in our own lab
Every donor test runs in our Irvine laboratory. Nothing is sent out, so your donor cycles are not waiting on a second lab.
Kits that ship to your clinic
Domestic, international and bulk donor kits, delivered to your clinic or provider, with instruction videos for the staff collecting the draw.
Pickup and results your way
Specimen pickup by IHD courier (California only) or the carrier you choose, and results by portal, fax, secure email, mail or EMR/EHR if connected.
A compliance-ready file
Download the FDA donor binder for your compliance file, with the donor screening assay documentation your establishment needs.
DONOR PANELS
Two panels: egg donors and sperm donors
Each panel covers the FDA-required communicable disease tests for the donor type. Reactive screens reflex to confirmatory or quantitative tests, as shown in the test names.
Questions about which panel fits your donors? Call (800) 820-8803, Monday to Friday 8am to 5pm.
REGULATORY MAPPING
FDA donor eligibility tests at a glance
Which tests apply to which donors under 21 CFR 1271.85,
and what specimen each one needs.
Collection timing (21 CFR 1271.80): specimens are collected at recovery or within 7 days before or after; oocyte donors up to 30 days before recovery. Retesting: anonymous semen donors are retested at least 6 months after donation (1271.85(d)). Exemptions such as sexually intimate partners are described in 1271.90. Sources: 21 CFR 1271.85, Testing donors · FDA: Testing donors of HCT/Ps · 21 CFR 1271.80.
ORDER KITS
Order FDA donor test kits
Choose domestic, international or bulk and complete the form to order. Kits are delivered to your clinic or provider, where a trained professional collects the donor's venous blood draw, plus a urine specimen for chlamydia and gonorrhea
Kit blood draw videos
IHD-FDA-Donor-Kit-Domestic
IHD-FDA-Donor-Kit- International
HOW IT WORKS
From kit order to result, without the back-and-forth
Three steps from ordering your kits to receiving results.
WHY IHDLAB
Juggling several labs vs. one donor testing partner
TEST DETAILS
What each donor test checks for
Reactive results go to the ordering clinic, agency or bank, which makes the donor eligibility determination.
Ready to test your donors?
Become an IHDLab donor-testing client
Tell us about your clinic, agency or bank, your donor volume and whether you need domestic, international or bulk kits. We will set up your account and kit ordering. Prefer to talk now? Call (800) 820-8803, Monday to Friday 8am to 5pm.
Getting started is simple
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Tell us about your clinic, agency or bank
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We set up your account and kit ordering
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Order kits and send donor specimens to our lab
FAQ