FDA.reportPublic FDA data

Clearblue

Primary DI
00633472602603
Brand
Clearblue
Company
SPD SWISS PRECISION DIAGNOSTICS GMBH
Model
Early Detection Pregnancy Test Detección Temprana
Catalog number
N/A
Device description
CLEARBLUE PREG VIS CB16 1CT TRAY US
Published
2026-06-25
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
K213379000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213379000Clearblue ® Early Pregnancy TestSpd Swiss Precision Diagnostics GmbH2022-09-21LCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10633472602600PackageGS124In Commercial Distribution
00633472602603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063347260260010633472602600
00633472602603006334726026036334726026030633472602603

GMDN Terms#

Term, Definition table
TermDefinition
Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalA 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 includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid detection of pregnancy, or as a predictor of adverse pregnancy outcomes (e.g., miscarriage) and/or trisomy 21 (Down syndrome). It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
800 321 3279xx@xx.xx

Regulatory Flags#

DUNS number
483609579
Device count
1
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
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
00633472600425ClearblueAdvanced Digital Ovulation Test2019-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00050428050460CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428082102CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087268CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428087589CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-03
00050428049556CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCX2026-06-02
06938444982801DAVIDEquinox Biotech Co., Ltd.LCX2026-06-01
00049696240482VeriQuickFOURSTAR GROUP INC.LCX2026-04-13
00072036734280Harris TeeterHarris Teeter, LLCLCX2026-02-27
00072036734297Harris TeeterHarris Teeter, LLCLCX2026-02-27
00075450847635Hy-Vee® 6 Days Sooner/Early Detection Pregnancy TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847666Hy-Vee® Analog Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00075450847673Hy-Vee® Digital Pregnancy Rapid TestGuangzhou Decheng Biotechnology Co., LTDLCX2026-02-20
00195515147545AmazonAMAZON.COM SERVICES LLCLCX2026-02-20
00195515147552AmazonAMAZON.COM SERVICES LLCLCX2026-02-20