biomerica.comHp Detect? Stool Antigen ELISA
Biomerica, Inc.
Biomerica
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2025099 | 3007981058 | Biomerica | 1 | N | 2026-01-01 | 17571 Von Karman Ave Irvine CA US 92614 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00083059010015 | EZ Detect Fecal Occult Blood Test - The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. | +1 949 645 2111 | info@biomerica.com |
| 00083059070330 | HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT - The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. | +1 949 645 2111 | info@biomerica.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 76866 | 1579719704 | K992799 | SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT | GGT | 2000-06-07 |
| 76866 | 1689061345 | K991469 | AWARE PAD | IYO | 1999-07-20 |
| 76866 | 1442485268 | K982608 | SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT | CKG | 1998-08-19 |
| 76866 | 1668322718 | K982491 | SANGUI BIOTECH, INC. CALCITONIN ELISA KIT | JKR | 1998-09-03 |
| 76866 | 1209562540 | K974306 | SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA | CEW | 1997-12-23 |
| 76866 | 1008598137 | K954256 | ANTI-TPO | JNL | 1995-11-27 |
| 76866 | 1175042221 | K951538 | BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT | CEP | 1995-07-11 |
| 76866 | 1975593923 | K936010 | THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY | DDC | 1994-07-18 |
| 76866 | 1911218983 | K915185 | GAP IGG H.PYLORI MODIFIED | LYR | 1992-03-04 |
| 76866 | 1525306399 | K860028 | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL | KHE | 1986-04-07 |
| 76866 | 1113054257 | K232892 | Hp Detect™ Stool Antigen ELISA | LYR | 2023-12-15 |
| 76866 | 1140360372 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | DJG | 2006-04-21 |
| 76866 | 1935191564 | K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | DRR | 2002-12-19 |
| 76866 | 1206025482 | K022589 | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE | LAF | 2002-10-28 |
| 76866 | 1060970567 | K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | LFG | 2002-07-17 |
| 76866 | 1656062899 | K013062 | BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT | MMI | 2002-01-08 |
| 76866 | 1243519323 | K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE | DIS | 2001-11-09 |
| 76866 | 1053914042 | K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE | DJR | 2001-10-15 |
| 76866 | 1466353357 | K012300 | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | JXM | 2001-09-17 |
| 76866 | 1078700870 | K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | LCM | 2001-08-09 |
| 76866 | 1457723777 | K011673 | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE | DKZ | 2001-07-31 |
| 76866 | 1362920973 | K011672 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE | LAF | 2001-07-31 |
| 76866 | 1747000246 | K011353 | ACON OPI ONE STEP OPIATES TEST STRIP, ACON OPI ONE STEP OPIATES TEST DEVICE | DJG | 2001-07-30 |
| 76866 | 1012644292 | K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | DIO | 2001-07-09 |
| 76866 | 1522480833 | K003856 | EZ-HCG URINE(PREGNANCY TEST) | JHI | 2001-02-21 |
| 76866 | 1569678420 | K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119 | DCK | 2001-07-20 |
| 76866 | 1622973907 | K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) | LDJ | 2001-03-15 |
| 76866 | 1010140007 | ||||
| 76866 | 1188210679 | ||||
| 76866 | 1265439316 | ||||
| 76866 | 1331623845 | ||||
| 76866 | 1676932851 | ||||
| 76866 | 1842741752 | ||||
| 76866 | 2052455191 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LYR | 2 | 2023-12-15 |
| DJG | 2 | 2006-04-21 |
| LAF | 2 | 2002-10-28 |
| DRR | 1 | 2002-12-19 |
| LFG | 1 | 2002-07-17 |
| MMI | 1 | 2002-01-08 |
| DIS | 1 | 2001-11-09 |
| DJR | 1 | 2001-10-15 |
| JXM | 1 | 2001-09-17 |
| LCM | 1 | 2001-08-09 |
| DKZ | 1 | 2001-07-31 |
| DCK | 1 | 2001-07-20 |
| DIO | 1 | 2001-07-09 |
| LDJ | 1 | 2001-03-15 |
| JHI | 1 | 2001-02-21 |
| GGT | 1 | 2000-06-07 |
| IYO | 1 | 1999-07-20 |
| JKR | 1 | 1998-09-03 |
| CKG | 1 | 1998-08-19 |
| CEW | 1 | 1997-12-23 |
| JNL | 1 | 1995-11-27 |
| CEP | 1 | 1995-07-11 |
| DDC | 1 | 1994-07-18 |
| KHE | 1 | 1986-04-07 |
PMN#
EZ-HCG URINE(PREGNANCY TEST)
BIOMERICA, INC.
FREE T4 MICROWELL EIA, MODEL #7019
BIOMERICA, INC.
TSH (MICROWELL) ELISA
BIOMERICA, INC.
T-3 MICROWELL EIA MODEL 7013
BIOMERICA, INC.
ANTI-TPO
BIOMERICA, INC.
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
BIOMERICA, INC.
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
BIOMERICA, INC.
GAP IGG H.PYLORI MODIFIED
BIOMERICA, INC.
GAP-IGG
BIOMERICA, INC.
GUDID#
Hp Detect Stool Antigen ELISA - The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient’s clinical information (history and symptoms). For Prescription Use Only.
2024-01-08
HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT - The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
2016-12-07
HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT - The hsCRP ELISA is intended for the quantitative determination of C-reactive protein (CRP) in human serum. Enhanced sensitivity measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
2020-07-01
EZ Detect Fecal Occult Blood Test - The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use.
2016-12-08
EZ Detect Colon Disease Test - Home Test For Hidden Blood in The Stool
2016-12-08
EZ Detect Fecal Occult Blood Test - The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use.
2020-07-01
EZ Detect Colon Disease Test - Home Test For Hidden Blood in The Stool
2020-07-01
EZ-SALMONELLA One-Step Salmonella species Rapid Test - The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.
2016-12-08
EZ-SALMONELLA One-Step Salmonella species Rapid Test - The Biomerica Salmonella test is a lateral flow immunoassay for the rapid determination of the presence of Salmonella species in human stool samples. The test is intended for professional use only.
2020-07-01
Aware Breast Self-Exam Pad - The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
2016-12-07
GAP®-IgG (Gastritis and Peptic Ulcer Test) - The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
2016-12-08
ACTH [Adrenocorticotropic Hormone] ELISA - The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.
2016-12-07
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
2016-12-07
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
2016-12-07
Myoglobin Enzyme Immunoassay Test Kit - The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
2016-12-07
TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT - The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
2016-12-08
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.
2016-12-08
Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only.
2016-12-08
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.
2016-12-08
EZ-hCG Urine Pregnancy Test - The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
2016-12-08
EZ-GIARDIA One-Step Giardia Test - The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only.
2016-12-08
EZ-SHIGELLA One-Step Shigella species Rapid Test - The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
2020-01-10
Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use.
2016-12-07
Aware Breast Self-Exam Pad - The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
2020-07-01
Aware Breast Self-Exam Pad - The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
2020-07-01
GAP®-IgG (Gastritis and Peptic Ulcer Test) - The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
2020-07-01
Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Intact-PTH ELISA is intended for the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. This assay is intended for in vitro diagnostic use.
2020-07-01
ACTH [Adrenocorticotropic Hormone] ELISA - The Biomerica ACTH ELISA is intended for the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human plasma. This assay is intended for in vitro diagnostic use.
2020-07-01
Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Calcitonin ELISA is intended for the quantitative determination of Calcitonin in human serum. This assay is intended for in vitro diagnostic use.
2020-07-01
EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica EPO ELISA is intended for the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
2020-07-01
Myoglobin Enzyme Immunoassay Test Kit - The Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum.
2020-07-01
TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT - The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).
2020-07-01
Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Cryptosporidium ELISA is intended for the qualitative detection of Cryptosporidium-specific antigen (CSA) in fecal specimens. This assay is intended for in vitro diagnostic use only.
2020-07-01
Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica Giardia ELISA is intended for the qualitative detection of Giardia antigen in fecal specimens. This assay is intended for research use only.
2020-07-01
E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] - The Biomerica E. histolytica/dispar ELISA is intended for the qualitative detection of Entamoeba specific antigen in fecal specimens. This assay is intended for in vitro diagnostic use only.
2020-07-01
EZ-SHIGELLA One-Step Shigella species Rapid Test - The Biomerica Shigella species test is a lateral flow immunoassay for the rapid determination of the presence of Shigella species in human stool samples. The test is intended for professional use only.
2020-07-01
EZ-hCG Urine Pregnancy Test - The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
2020-07-01
EZ-GIARDIA One-Step Giardia Test - The Biomerica Giardia test is a rapid chromatographic immunoassay for the qualitative detection of Giardia antigens in human stool samples. The In Vitro test is intended for professional use only.
2020-07-01