FDA.reportPublic FDA data

Premom Pregnancy Test Strip (30 test kit)

Primary DI
10855944007311
Brand
Premom Pregnancy Test Strip (30 test kit)
Company
EASY HEALTHCARE CORPORATION
Model
PM1-S
Catalog number
PMS-130
Device description
Premom Pregnancy Test Strip (30 test kit)
Published
2018-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855944007311PackageGS180In Commercial Distribution
00855944007314PrimaryGS10
30855944007315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085594400731110855944007311
00855944007314008559440073148559440073140855944007314
3085594400731530855944007315

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapidA 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 may include intact HCG, nicked HCG, free alpha-HCG subunits and/or free beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080278407
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038638864Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17
00810038638911Easy@Home Dual Digital ThermometerEBT-0132025-07-17
00810038633992Easy@Home Dual Digital ThermometerEBT-0132023-01-30
10810038638093Easy@Home Marijuana Test Strip(THC 20)ESTH-215ESTH-215-52025-07-10
00810038637365easy@Home TENS AND MUSCLE STIMULATOREHE0802025-04-17
10810038636846Easy@Home Pregnancy Test (5 tests) EZW1-MDEZW1-MD-52024-11-08
10810038636266Easy@Home Blood Pressure Monitor EBP-095 BlackEBP-0952024-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164510006ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510019ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510026ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510033ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510040ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510057ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
80810164510064ACESO Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510112Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510129Atida Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510150Atida Digital Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510693Atida Early Pregnancy TestACESO LABORATORIES INC.LCX2026-03-23
00810164510709Atida DIGITAL EARLY PREGNANCY TESTACESO LABORATORIES INC.LCX2026-03-23
00812203030889ChemtrueCHEMTRON BIOTECH INCLCX2026-03-10
00072036704283Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036714299Harris TeeterHarris Teeter, LLCLCX2026-02-27
30075450847636Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847642Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847659Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847667Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
30075450847674Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
10751774000037DG HealthDOLGENCORP, LLCLCX2026-02-20
10311917083800WalgreensWALGREEN CO.LCX2026-02-17
10311917083954WalgreensWALGREEN CO.LCX2026-02-17
10311917084029WalgreensWALGREEN CO.LCX2026-02-17
00070552251120Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
00070552351134Winco Foods One Step Pregnancy TestWINCO FOODS, LLCLCX2026-02-09
10311917083459WalgreensWALGREEN CO.LCX2026-02-05
10311917083510WalgreensWALGREEN CO.LCX2026-02-05
10311917083572WalgreensWALGREEN CO.LCX2026-02-05
50045611010005SURESIGN™ Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-01-28