FDA.reportPublic FDA data

HealthyMe Early Detection Pregnancy Test

Primary DI
10682607630308
Brand
HealthyMe Early Detection Pregnancy Test
Company
ACON LABORATORIES, INC.
Model
L031-20198
Catalog number
763030
Device description
Early Detection Pregnancy Test
Published
2024-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193318000Distinct® Early Detection Pregnancy TestACON Laboratories, Inc.2020-08-20LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10682607630308PackageGS16In Commercial Distribution
20682607630305PackageGS14In Commercial Distribution
00682607630301PrimaryGS10
00682607002276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068260763030810682607630308
2068260763030520682607630305
00682607630301006826076303016826076303010682607630301
00682607002276006826070022766826070022760682607002276

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810107290132Flowflex Plus Strep A Rapid Test CassetteL03A-R0115L03A-R01152025-12-01
00810107290156Flowflex Plus Strep A Rapid Test StripL03A-R0125, L03A-R0135L03A-R0125, L03A-R01352025-12-01
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1012026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1042026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSOGS-211G135-20U-1052026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1012026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1022026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1042026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSOGS-511GK135-201-1052026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONOGS-211G125-22U-1012026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMOGM-211G115-20U-1012026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-21U-1012026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-22U-1012026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-23U-1012026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMOGM-212G115-20W-1012026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-21W-1012026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-22W-1012026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-23W-1012026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-511GK115-201-1012026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METEROGM-511GK115-221-1012026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50045611956013ept Pregnancy (hCG) Enhanced Sensitivity Rapid Test Midstream (Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-29
50045611956044ept Digital Early Pregnancy Test Midstream(Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-29
00022600230021First Response™ Daily Check Pregnancy Test KitCHURCH & DWIGHT CO., INC.LCX2026-10-28
00045611956049ept Digital Early Pregnancy Test Midstream(Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-27
06978151200195HCG One Step Pregnancy Test Midstream OTCHangzhou Aichek Medical Technology Co., Ltd.LCX2026-10-27
00045611951013ept Pregnancy (hCG) Rapid Test Midstream (Urine)Hangzhou AllTest Biotech Co., Ltd.LCX2026-10-26
06978151200201HCG One Step Pregnancy Test Strip OTCHangzhou Aichek Medical Technology Co., Ltd.LCX2026-10-23
10850078377378iHealthiHealth Labs Inc.LCX2026-10-22
00846036009910GoodsenseGEISS, DESTIN & DUNN, INCLCX2026-10-13
00311917090498WalgreensWALGREEN CO.LCX2026-10-12
06923304600193U Pregnancy TestWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-28
86950996041122Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-26
86950996013099Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
86950996019039Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-25
06950996006323Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996030694Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06950996067577Orient GeneZhejiang Orient Gene Biotech Co.,Ltd.LCX2026-07-23
06923304600124FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600131FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600155FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600162FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
06923304600186FERTICAREWeihai Kangzhou Biotechnology Engineering Co., LtdLCX2026-07-21
00036800028326TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028333TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028340TopCare HealthTopco Associates, LLCLCX2026-07-13
00036800028357TopCare HealthTopco Associates, LLCLCX2026-07-13
00810174470543HORMONElife™WONDFO USA CO., LTD.LCX2026-06-26
00633472602603ClearblueSPD SWISS PRECISION DIAGNOSTICS GMBHLCX2026-06-25
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428082102CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03