Home GUDID 08305901007151 EZ-SALMONELLA One-Step Salmonella species Rapid Test
Primary DI 08305901007151
Brand EZ-SALMONELLA One-Step Salmonella species Rapid Test
Company BIOMERICA, INC.
Model 1007-15
Device description 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.
Published 2016-12-08
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name GRM Antisera, All Groups, Salmonella Spp.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GRM Antisera, All Groups, Salmonella Spp. Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08305901007151 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08305901007151 08305901007151 8305901007151
GMDN Terms# Term, Definition table Term Definition Multiple Salmonella species antigen IVD, kit, immunochromatographic test (ICT), rapid A collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of antigens from one or multiple species of Salmonella bacteria 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.
Regulatory Flags# DUNS number 067647321 Device count 1 Premarket exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00083059070835 Hp Detect Stool Antigen ELISA 7083 7083 2024-01-08 08305900070330 HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT 7033 2016-12-07 00083059070330 HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT 7033 2020-07-01 08305900010015 EZ Detect Fecal Occult Blood Test 1001 2016-12-08 08305900100013 EZ Detect Colon Disease Test 1000-1 2016-12-08 00083059010015 EZ Detect Fecal Occult Blood Test 1001 2020-07-01 00083059100013 EZ Detect Colon Disease Test 1000-1 2020-07-01 00083059100754 EZ-SALMONELLA One-Step Salmonella species Rapid Test 1007-15 2020-07-01 08305900012033 Aware Breast Self-Exam Pad 1203 2016-12-07 08305900070040 GAP®-IgG (Gastritis and Peptic Ulcer Test) 7004 2016-12-08 08305900070231 ACTH [Adrenocorticotropic Hormone] ELISA 7023 2016-12-07 08305900070248 Calcitonin ELISA [Enzyme-Linked ImmunoSorbent Assay] 7024 2016-12-07 08305900070255 EPO [Erythropoietin] ELISA [Enzyme-Linked ImmunoSorbent Assay] 7025 2016-12-07 08305900070309 Myoglobin Enzyme Immunoassay Test Kit 7030 2016-12-07 08305900070316 TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT 7031 2016-12-08 08305900070637 Cryptosporidium ELISA [Enzyme-Linked ImmunoSorbent Assay] 7063 2016-12-08 08305900070699 Giardia ELISA [Enzyme-Linked ImmunoSorbent Assay] 7069 2016-12-08 08305900070781 E. histolytica ELISA [Enzyme-Linked ImmunoSorbent Assay] 7078 2016-12-08 08305901048253 EZ-hCG Urine Pregnancy Test 1048-25 2016-12-08 08305901501154 EZ-GIARDIA One-Step Giardia Test 1501-15 2016-12-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05060472461957 Rapid Polyvalent Salmonella Diagnostic Sera RSD 1 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472461964 Rapid Polyvalent Salmonella Diagnostic Sera RSD 2 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472461971 Rapid Polyvalent Salmonella Diagnostic Sera RSD 3 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472462671 Monovalent Flagella Salmonella Antisera - Factor 5 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472462688 Monovalent Flagella Salmonella Antisera - Factor 6 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472462695 Monovalent Flagella Salmonella Antisera - Factor 7 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472462701 Monovalent Flagella Salmonella Antisera - Factor z6 PRO-LAB, INCORPORATED GRM 2022-12-24 05060472461933 Polyvalent Flagella Salmonella Antisera - H Phase 1 & 2 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472461940 Polyvalent Flagella Salmonella Antisera - H Phase 2, Factors 1, 2, 5, 6, 7, z6 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462039 Monovalent Somatic Salmonella Antisera - Group D, Factor 9 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462046 Monovalent Somatic Salmonella Antisera - Group B/D, Factor 12 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462176 Monovalent Somatic Salmonella Antisera - Group K, Factor 18 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462183 Monovalent Somatic Salmonella Antisera - Group L, Factor 21 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462190 Monovalent Somatic Salmonella Antisera - Group M, Factor 28 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462206 Monovalent Somatic Salmonella Antisera - Group N, Factor 30 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462213 Monovalent Somatic Salmonella Antisera - Group O, Factor 35 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462220 Monovalent Somatic Salmonella Antisera - Group P, Factor 38 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462237 Monovalent Somatic Salmonella Antisera - Group Q, Factor 39 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462244 Monovalent Somatic Salmonella Antisera - Group R, Factor 40 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462251 Monovalent Somatic Salmonella Antisera - Group S, Factor 41 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462268 Monovalent Somatic Salmonella Antisera - Vi Factor PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462275 Monovalent Somatic Salmonella Antisera - Factor 55 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462282 Monovalent Flagella Salmonella Antisera - Factor a PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462299 Monovalent Flagella Salmonella Antisera - Factor b PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462305 Monovalent Flagella Salmonella Antisera - Factor c PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462312 Monovalent Flagella Salmonella Antisera - Factor d PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462329 Monovalent Flagella Salmonella Antisera - E Complex eh, enx, enz15 PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462336 Monovalent Flagella Salmonella Antisera - Factor eh PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462343 Monovalent Flagella Salmonella Antisera - Factor enx PRO-LAB, INCORPORATED GRM 2022-12-23 05060472462350 Monovalent Flagella Salmonella Antisera - Factor enz15 PRO-LAB, INCORPORATED GRM 2022-12-23
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