One Step Pregnancy Test - 10001
2021-10-15
UNIVERSAL MEDITECH INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011908678 | 3011908678 | UNIVERSAL MEDITECH INC. | 1 | Y | 2020-04-25 | 1320 E Fortune Ave Suite 102 Fresno CA US 93725 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 192789 | 1351014070 | K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | JMT | 2000-01-03 |
| 192789 | 1329220348 | K974060 | MINISTRIP/ SERUM AND URINE COMBO HCG TEST | JHI | 1998-04-09 |
| 192789 | 1313130246 | K974059 | ONE STEP MIDSTREAM HCG PREGNANCY TEST | LCX | 1998-04-09 |
| 192789 | 1264871330 | K974009 | PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG | JHI | 1998-03-13 |
| 192789 | 1777340736 | K970176 | HCG CONTROLS | JJX | 1997-02-06 |
| 192789 | 1549011020 | K963133 | PS-UNIT CASSETTE/SERUM HCG | JHI | 1996-11-18 |
| 192789 | 1275040639 | K963132 | MINI STRIP/SERUM HCG | JHI | 1996-11-18 |
| 192789 | 1128972166 | K951705 | MINISTRIP HCG | JHI | 1995-10-03 |
| 192789 | 1038044598 | K121231 | IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST | NGT | 2012-07-30 |
| 192789 | 1274128298 | K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | KHE | 2012-12-19 |
| 192789 | 1693984244 | K110889 | IND ONE STEP HCG URINE PREGNANCY TEST (STRIP) | LCX | 2011-06-20 |
| 192789 | 1423638057 | K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | NGJ | 2012-04-17 |
| 192789 | 1143189227 | K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | KHE | 2010-07-19 |
| 192789 | 1376298352 | K063390 | URINE CHEMISTRY ANALYZER UR-50 | JIL | 2007-03-01 |
| 192789 | 1273585262 | K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | DKZ | 2006-08-07 |
| 192789 | 1290630703 | K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | JHI | 2005-12-16 |
| 192789 | 1353253622 | K052662 | ONE STEP FSH MENOPAUSAL TEST | CGJ | 2005-11-30 |
| 192789 | 1964948670 | K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | JHI | 2005-05-16 |
| 192789 | 1893961537 | K023638 | CASSETTE/URINE HCG | LCX | 2003-01-03 |
| 192789 | 2025366459 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | 2002-07-23 |
| 192789 | 1019477310 | ||||
| 192789 | 1042165083 | ||||
| 192789 | 1127357254 | ||||
| 192789 | 1371940998 | ||||
| 192789 | 1381785312 | ||||
| 192789 | 1643270697 | ||||
| 192789 | 1681871241 | ||||
| 192789 | 1696575990 | ||||
| 192789 | 1765188739 | ||||
| 192789 | 1791448328 | ||||
| 192789 | 1925884719 | ||||
| 192789 | 1927043088 | ||||
| 192789 | 1967256272 |
Product Codes Associated With Registrations#
GUDID#
DoublecheQ Pregnancy Test - The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in urine. The result can be read visually in minutes to indicate a positive or negative result for pregnancy.
2019-06-03
One Step Ovulation Test - 20001
2021-10-15
One Step Menopausal Test - 21001
2021-10-15
DoublecheQ Pregnancy Test - The DoublecheQ Pregnancy Test is designed to be used for a qualitative determination of elevated human chorionic gonadotropin in urine. The result can be read visually in minutes to indicate a positive or negative result for pregnancy.
2019-06-03