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Spermac Stain - Fixative

FDA UDI

Class II (US FDA UDI)

by Vitrolife AB

Identity

Trade Name
Spermac Stain - Fixative FDA UDI
Generic Name
10% Formaldehyde solution IVD FDA UDI
Device Name
Spermac Stain - Fixative, 50mL FDA UDI
Model / Reference
15515 FDA UDI
Description
Spermac Stain - Fixative, 50mL FDA UDI

Identifiers

Primary DI / UDI-DI
00805360018425 FDA UDI
FDA Product Code
POV FDA UDI
GMDN Term
10% Formaldehyde solution IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5220 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: 10% Formaldehyde solution IVD

Spermac Stain - Fixative by Vitrolife AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as 10% Formaldehyde solution IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vitrolife AB

Sources (1)

  • FDA UDI 73f1b26b-dc11-460c-a48c-4c49eec19888 33 fields · synced May 30, 2026