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Premier Value

FDA UDI

Class II (US FDA UDI)

by Pharmacy Value Alliance, Llc

Identity

Trade Name
Premier Value FDA UDI
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name
Premier Value DPS +/- Blue Cap 2 ct FDA UDI
Model / Reference
Advanced One-Step Pregnancy Test FDA UDI
Description
Premier Value DPS +/- Blue Cap 2 ct FDA UDI

Identifiers

Primary DI / UDI-DI
00840986037108 FDA UDI
510(k) Number
K042280 FDA UDI
FDA Product Code
LCX FDA UDI
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1155 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Premier Value by Pharmacy Value Alliance, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042280 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pharmacy Value Alliance, Llc

Sources (1)

  • FDA UDI 9340f027-5508-498f-91b2-3cf4c8965776 37 fields · synced Jun 8, 2026