Model: 11012450MD
DI: 00049696240482
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-13
Current Version: 2026-05-22
Description
VQ ONE STEP PREGNANCY TEST
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
33dda480-6839-4690-9388-85a35c6c9d7b
Distribution Status:
In Commercial Distribution
DUNS Number:
656091279
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00049696240482
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33819
Name: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.
FDA Product Codes
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
Premarket Submissions
Submission Number:
K212418
Supplement Number:
000