FDA.reportPublic FDA data

Dealmed

Primary DI
00817415021069
Brand
Dealmed
Company
DEALMED MEDICAL SUPPLIES LLC
Model
788525
Catalog number
788525
Device description
Pregnancy hCG Test Cassette, 25/Box
Published
2021-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
JHIVisual, pregnancy hCG, prescription use
LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043443000ONE STEP HCG URINE PREGNANCY TESTGuangzhou Wondfo Biotech Co., Ltd.2005-04-08LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817415021069PrimaryGS10
00817415020987Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817415021069008174150210698174150210690817415021069
00817415020987008174150209878174150209870817415020987

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00between 39 and 86 Degrees Fahrenheit
Storage Environment Temperature39 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
068586441
Device count
25
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859140003200Dealmed7864227864222026-10-08
00859140003217Dealmed7864247864242026-10-08
00817415020871Dealmed7873557873552020-09-11
00859140003828Dealmed7873517873512020-09-11
00859140003835Dealmed7873527873522020-09-11
00859140003842Dealmed7873537873532020-09-11
00859140003859Dealmed7873547873542020-09-11
00817415020086Dealmed7875307875302022-08-29
00859140003125Dealmed7875207875202022-08-29
10817415021653Dealmed7831327831322021-09-30
10817415021844DEALMED7838227838222021-09-17
00859140003750Dealmed8591400037577830432020-09-11
00859140003798Dealmed7838047838042020-12-04
00817415021861Dealmed7864017864012021-04-26
00817415021878Dealmed7864027864022021-04-26
00817415021885Dealmed7864037864032021-04-26
00817415023049Dealmed7864047864042022-07-18
00817415023087Dealmed7864087864082022-07-28
00817415023063Dealmed7864067864062022-07-28
00817415020468Dealmed7836197836192020-12-04

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
06978151200263HCG One Step Pregnancy Test Strip RxHangzhou Aichek Medical Technology Co., Ltd.JHI2026-10-27
06978151200270HCG One Step Pregnancy Test Midstream RxHangzhou Aichek Medical Technology Co., Ltd.JHI2026-10-27
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