Identity
- Trade Name
- VeriQuick FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- PREGNANCY TEST 2CT FDA UDI
- Model / Reference
- 11012450MB FDA UDI
- Description
- PREGNANCY TEST 2CT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00049696737746 FDA UDI
- 510(k) Number
- K150022 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA)
VeriQuick by Fourstar Group Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total human chorionic gonadotropin IVD, kit, enzyme immunoassay (EIA).
- Pregmate 50 Ovulation and 20 Pregnancy Test Strips — PREGMATE LLC · Class I
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- Pregmate Pregnancy Test Strips (50 Count) — PREGMATE LLC · Class II
- Monobind AccuBind hCG ELISA Kit - 192 Wells — MONOBIND, INC. · Class II
- R Med Pregnancy Test Cassettes — R MEDICAL SUPPLY INC · Class II
- Dimension Human Chorionic Gonadotropin Flex reagent cartridge — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K150022 also covers:
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- LEADER — Cardinal Health 110, Inc.
- Family Wellness — FOURSTAR GROUP INC.
- Family Wellness — FOURSTAR GROUP INC.
- VeriQuick — FOURSTAR GROUP INC.
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- GOODSENSE — GEISS, DESTIN & DUNN, INC
- Stix — Get Stix Inc.
- Modern Fertility Pregnancy Test — MODERN HEALTH
- Modern Fertility Pregnancy Test — MODERN HEALTH
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fourstar Group Inc.
Sources (1)
- FDA UDI fd61ed32-60e2-41e7-8ad6-61163c6e0588 34 fields · synced Jun 8, 2026