FDA.report

SurePredict(R)

Primary DI
00863772000322
Brand
SurePredict(R)
Company
Ushealthtest
Model
1
Catalog number
SP20.8.16
Device description
HCG Strip Test
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

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
00863772000308PackageGS1375In Commercial Distribution
00863772000315PackageGS120In Commercial Distribution
00863772000322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00863772000308008637720003088637720003080863772000308
00863772000315008637720003158637720003150863772000315
00863772000322008637720003228637720003220863772000322

GMDN Terms

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

Contacts

PhoneEmail
8668378669info@ushealthtests.com

Regulatory Flags

DUNS number
129582917
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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 Sharing Product Codes

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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