Fertility Solutions

FDA UDI

Class I (US FDA UDI)

by Fertility Solutions, Inc.

Identity

Trade Name: Fertility Solutions FDA UDI
Generic Name: Microscope counting chamber IVD FDA UDI
Device Name: Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer FDA UDI
Model / Reference: SA400 FDA UDI
Description: Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer FDA UDI

Identifiers

Catalog Number: SA400 FDA UDI
Primary DI / UDI-DI: 00860010518199 FDA UDI
FDA Product Code: GHO FDA UDI
GMDN Term: Microscope counting chamber IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 864.6160 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Depth — 20 Micrometer FDA UDI

Category: Microscope counting chamber IVD

Fertility Solutions by Fertility Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LensHooke semen Test Cassette — BONRAYBIO CO., LTD. · Class II
LensHooke semen Test Cassette — BONRAYBIO CO., LTD. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fertility Solutions, Inc.

Sources (1)

FDA UDI 2ccf14c8-cdbe-41f2-8c15-29483ddccc0f 36 fields · synced May 30, 2026