| Document |
Parent |
Analyte |
Analyte Specialty |
Complexity |
Effective Date |
|
HY-VEE, INC., Hy-Vee 6 Days Sooner/Early Detection Pregnancy Test
|
| CR250764 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
01/30/2026 |
|
Walmart Inc., equate 6 Days Sooner Pregnancy Test Strip
|
| CR250386 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
07/02/2025 |
|
Kingsway Pharmaceuticals dba NFI, LLC, SURESIGN Early Detection Pregnancy Test
|
| CR250382 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
07/02/2025 |
|
Phase Diagnostics, Inc., INDICAID Early Detection Pregnancy Test Strip
|
| CR250304 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
06/10/2025 |
|
Kozekoze LLC, Kozekoze Early Detection Pregnancy Test
|
| CR250023 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
02/20/2025 |
|
Medical Group Care, LLC, exchange select Early Detection Pregnancy Test 6 Days Sooner
|
| CR250024 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
02/19/2025 |
|
Medical Group Care, LLC, MGC Health Early Detection Pregnancy Test
|
| CR240735 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
12/30/2024 |
|
Dochek USA INC., Amazewell Early Detection Pregnancy Test Midstream
|
| CR240738 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
12/20/2024 |
|
Dochek USA INC., Amazewell Early Detection Pregnancy Test Strip
|
| CR240738 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
12/20/2024 |
|
Genabio Diagnostics Inc., GENACHECK EARLY RESULT PREGNANCY TEST
|
| CR240492 |
K240643 |
Urine hCG by visual color comparison tests |
Endocrinology |
WAIVED |
09/12/2024 |
