Good Neighbor Pharmacy

FDA UDI

Class I (US FDA UDI)

by Amerisourcebergen Drug Corporation

Identity

Trade Name: Good Neighbor Pharmacy FDA UDI
Generic Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Device Name: A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy Test. FDA UDI
Model / Reference: Early Ovulation Test FDA UDI
Description: A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy Test. FDA UDI

Identifiers

Primary DI / UDI-DI: 00087701433634 FDA UDI
510(k) Number: K042280 FDA UDI
K981271 FDA UDI
FDA Product Code: CEP FDA UDI
LCX FDA UDI
GMDN Term: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1485 FDA UDI
862.1155 FDA UDI
Commercial Distribution: Not 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Good Neighbor Pharmacy by Amerisourcebergen Drug Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042280 also covers:

K981271 also covers:

H.E.B — H. E. BUTT GROCERY COMPANY
Kroger — KROGER CO., THE
Meijer — MEIJER, INC.
Clearblue — SPD SWISS PRECISION DIAGNOSTICS GMBH
Topcare — Topco Associates, LLC
CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Equate — Walmart Stores

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Amerisourcebergen Drug Corporation

Sources (1)

FDA UDI e6466ed9-bd1a-4ebe-a7cb-f579ff51b37b 37 fields · synced Jun 1, 2026