SurePredict(R) 1

by Ushealthtest

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00863772000322 UDI-DI	Date6 Oct 2016Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: SurePredict(R)
Generic Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Model / Ref / Catalog: 1, SP20.8.16

Primary DI / UDI-DI: 00863772000322
FDA Product Code: LCX
GMDN Term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

Device Class: Class II
Regulation Number: 862.1155
GUDID distribution status: In Commercial Distribution

Properties

Single Use
Over-the-Counter
Convenience Kit
Combination Product
Lot / Batch Number
Expiration Date

Other properties (8)

Sterile: No
Implantable: No
Contains Latex: No
Prescription Use: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No