FDA.report

Complete Circle Health

Primary DI
00860383000307
Brand
Complete Circle Health
Company
PWL SOLUTIONS LLC
Model
LMBCS20A99
Device description
Home Midstream Pregnancy Test
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LCXKit, Test, Pregnancy, Hcg, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
LCXKit, Test, Pregnancy, Hcg, Over The CounterClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860383000307PrimaryGS10
00860383000314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860383000307008603830003078603830003070860383000307
00860383000314008603830003148603830003140860383000314

GMDN Terms

TermDefinition
Human chorionic gonadotropin beta-subunit (beta-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 beta-subunit human chorionic gonadotropin (beta-HCG), which may include free beta-HCG subunit, free nicked beta-HCG subunit and/or beta subunit core fragment, 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.

Device Sizes

TypeValueUnit
Width6Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
855-444-2105plinville.pwlsolutions@gmail.com

Regulatory Flags

DUNS number
080312287
Device count
3
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
true
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 Sharing Product Codes

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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