FDA.reportPublic FDA data

CVP Health

Primary DI
00761706168530
Brand
CVP Health
Company
SPD SWISS PRECISION DIAGNOSTICS GMBH
Model
One Step Pregnancy Test
Catalog number
N/A
Device description
McLane (CVP Health) DPS +/-
Published
2024-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K042280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042280000FACT PLUS ONE-STEP PREGNANCY TEST KITUnipath , Ltd.2004-09-10LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10761706168537PackageGS124In Commercial Distribution
20761706168534PackageGS16In Commercial Distribution
00761706168530PrimaryGS10
00633472000126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076170616853710761706168537
2076170616853420761706168534
00761706168530007617061685307617061685300761706168530
00633472000126006334720001266334720001260633472000126

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-899-7353xx@xx.xx

Regulatory Flags#

DUNS number
483609579
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00633472602603ClearblueEarly Detection Pregnancy Test Detección Temprana N/A2026-06-25
00633472602313ClearblueEarly Digital Pregnancy TestN/A2024-02-06
00633472602559ClearblueSmart Ovulation TestN/A2026-05-06
00633472602566ClearblueSmart Ovulation TestN/A2026-05-06
00633472602573ClearblueSmart Ovulation TestN/A2026-05-06
00381519194696ClearbluePeriod Cycle Tracker- CBApp-1N/A2026-03-23
00633472600760ClearblueDigital Ovulation Test2019-04-17
00633472601156Clearblue Pregnancy Test Combo Pack2016-09-14
00633472602245ClearblueMenopause Stage IndicatorN/A2023-07-31
00633472602375ClearblueBirth Control KitN/A2024-12-11
00633472602382ClearblueDigital Ovulation TestN/A2024-10-30
00633472602535ClearblueDigital Ovulation TestN/A2025-07-30
10633472602532ClearblueDigital Ovulation TestN/A2025-07-30
00041163502987Equaline Digital Pregnancy Test2021-04-19
00041163504448EqualineDigital Wide-Tip Pregnancy TestN/A2025-03-31
10041163504445EqualineDigital Wide-Tip Pregnancy TestN/A2025-03-31
00633472602481ClearblueEarly Assurance Combo Pregnancy TestsN/A2025-02-05
10633472602488ClearblueEarly Assurance Combo Pregnancy TestsN/A2025-02-05
00633472276897Clearblue Digital Pregnancy Test2019-07-29
00633472600401ClearblueAdvanced Digital Ovulation Test2019-04-17

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