FDA.reportPublic FDA data

UCP HOME

Primary DI
20817038021211
Brand
UCP HOME
Company
UCP BIOSCIENCES, INC.
Model
hCG strip
Catalog number
hCG strip
Device description
UCP HOME Pregnancy Test Strip
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038021211PackageGS140In Commercial Distribution
10817038021214PrimaryGS10
00817038021217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802121120817038021211
1081703802121410817038021214
00817038021217008170380212178170380212170817038021217

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 Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
163610020
Device count
50
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817038021955u-Card TM Drug Test Screen 3 panel Test CardU-DOA-234LU-DOA-234L2018-11-01
10817038021962u-Cup TM Drug Test Screen 8 Panel Drug Test CupU-CUP-384U-CUP-3842018-11-01
10817038021979UCP Compact Drug Test CupsUCC-A1001M-A3AUCC-A1001M-A3A2018-11-26
10817038022044U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242020-10-23
10817038022051u-CardTM Drug Test ScreenU-DOA-654U-DOA-6542020-11-09
10817038022068U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242021-05-24
108170380220756 Panel Drug Test CupU-CUP-2064-3ADU-CUP-2064-3AD2021-10-13
10817038022099AYDMED Rapid Multi-Drug Test Dip CardDOA-3174-061DOA-3174-0612022-03-01
10817038022112u-Card Drug Test ScreenU-MET-114LU-MET-114L2022-06-16
10817038022129OEM 81-13 Drug Test U-DOA-134U-DOA-1342023-04-07
10817038022136OEM 81-13 Drug Test U-DOA-654U-DOA-6542023-04-07
10817038022143OEM 81-13 Drug Test U-DOA-254U-DOA-2542023-04-07
10817038022150OEM 81-13 Drug Test U-DOA-264U-DOA-2642023-04-07
10817038022167OEM 81-13 Drug Test U-DOA-244U-DOA-2442023-04-07
10817038022211u-CardTM Drug Test Screen 12 Panel Test Card U-DOA-20124U-DOA-201242024-01-04
10817038022228OEM 81-13 Drug Test 5 Panel Test CupU-CUP-654U-CUP-6542024-04-09
10817038022235OEM 81-13 Drug Test 6 Panel Test CupU-CUP-264U-CUP-2642024-04-09
10817038022242inSight 12 Panel Drug Test CupIS-12P-CWIS-12P-CW2024-05-16
1081703802225910 Panel Drug Test CupU-CUP-13104U-CUP-131042025-03-24
10817038022266u-CupTM Drug Test ScreenU-DUD-20124U-DUD-201242025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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