This page includes the latest FDA filings for Stanbio Laboratory L P. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| STANBIO LABORATORY, L.P. | Uri-Trak 120 M Urine Analyzer G1300-001 | 2023-06-16 |
| STANBIO LABORATORY, L.P. | HGB Controls - High 3063-006 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | HGB Controls - High 3063-003 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | HGB Controls - Normal 3062-006 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | HGB Controls - Normal 3062-003 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | HGB Controls - Low 3061-006 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | HGB Controls - Low 3061-003 | 2021-04-08 |
| STANBIO LABORATORY, L.P. | Standard 1 A469-97 | 2020-03-02 |
| STANBIO LABORATORY, L.P. | HemoPoint H2 DMS G3500-001 | 2020-01-01 |
| STANBIO LABORATORY, L.P. | Excel® Chemistry Analyzer (Spanish) G7700S-001 | 2019-12-23 |
| STANBIO LABORATORY, L.P. | Excel® Chemistry Analyzer G7700E-001 | 2019-12-23 |
| STANBIO LABORATORY, L.P. | B-Ketone Control Solution 7024-204 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | Blood Glucose Control Solution 7014-204 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB B-Ketone Test Strips 7020-100 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB B-Ketone Test Strips 7020-050 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB B-Ketone Test Strips 7020-025 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB Blood Glucose Test Strips 7010-100 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB Blood Glucose Test Strips 7010-050 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB Blood Glucose Test Strips 7010-025 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site WB Dual Analyte Measurement System 7000-001 | 2019-11-26 |
| STANBIO LABORATORY, L.P. | STAT-Site Hgb Controls 503000 | 2019-09-02 |
| STANBIO LABORATORY, L.P. | Standard 2 A469-98 | 2019-05-31 |
| STANBIO LABORATORY, L.P. | Glycated Serum Protein Linearity Set 2380-201 | 2019-04-08 |
| STANBIO LABORATORY, L.P. | STAT-Site M Hgb Cards 901025 | 2019-04-01 |
| STANBIO LABORATORY, L.P. | Ketone Urine Controls 4020-005 | 2019-03-19 |
| STANBIO LABORATORY, L.P. | Ketone Serum Controls 4010-002 | 2019-03-19 |
| STANBIO LABORATORY, L.P. | Nitro-tab Ketone Tablets 4000-100 | 2019-03-19 |
| STANBIO LABORATORY, L.P. | RaPET® s-LE 1160-050 | 2019-02-04 |
| STANBIO LABORATORY, L.P. | RELY Mono 6200-020 | 2018-11-08 |
| STANBIO LABORATORY, L.P. | Triglyceride LiquiColor® (Mono) 2200-225 | 2018-06-18 |
| STANBIO LABORATORY, L.P. | TRUE® 20 Sample Pack 1430-003 | 2018-06-15 |
| STANBIO LABORATORY, L.P. | QuPID® Plus Sample Pack 1230-003 | 2018-06-15 |
| STANBIO LABORATORY, L.P. | Reference Solution A469-99 | 2018-04-18 |
| STANBIO LABORATORY, L.P. | Bi-Level Hgb Controls 3065-201 | 2018-04-18 |
| STANBIO LABORATORY, L.P. | TDM/B-Hydroxybutyrate Bi-Level Controls 2465-605 | 2018-04-18 |
| STANBIO LABORATORY, L.P. | TDM/B-Hydroxybutyrate Tri-Level Controls 2460-605 | 2018-04-18 |
| STANBIO LABORATORY, L.P. | Bi-Level Hgb Controls 3065-601 | 2018-04-18 |
| STANBIO LABORATORY, L.P. | Sirrus® Urea Nitrigen (BUN) Liqui-UV® S2020-600 | 2018-04-17 |
| STANBIO LABORATORY, L.P. | Urea Nitrogen (BUN) Test 0580-250 | 2018-04-17 |
| STANBIO LABORATORY, L.P. | Urea Nitrogen (BUN) Liqui-UV® 2020-500 | 2018-04-17 |
| STANBIO LABORATORY, L.P. | Urea Nitrogen (BUN) Liqui-UV® 2020-430 | 2018-04-17 |
| STANBIO LABORATORY, L.P. | Sirrus® Gamma-GT LiquiColor® S2960-600 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® ALT/SGPT Liqui-UV® S2930-600 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® AST/SGOT Liqui-UV® S2920-600 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Triglyceride LiquiColor® S2200-750 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Uric Acid LiquiColor® S1045-750 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Total Cholesterol LiquiColor® S1010-750 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Phosphorus Liqui-UV® S0830-750 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Direct LDL Cholesterol LiquiColor® S0710-540 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Direct HDL Cholesterol LiquiColor® S0590-540 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Total Iron LiquiColor® S0370-600 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Sirrus® Albumin LiquiColor® S0285-750 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Ser-T-Fy 2, Level 2 Control G428-86 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Ser-T-Fy 1, Level 1 Control G427-86 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | hCG Tri-Level Serum Controls 1235-305 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | hCG Bi-Level Urine Controls 1225-205 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Cholesterol Standard (200 mg/dL) 1012-030 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Ser-T-Cal Multicalibrator 0550-605 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Uric Acid LiquiColor® 1045-225 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Uric Acid LiquiColor® 1045-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Triglyceride LiquiColor® 2100-225 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Triglyceride LiquiColor® 2100-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Triglyceride LiquiColor® (Mono) 2200-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Micro Protein (CSF/Urine) LiquiColor® 0345-212 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Phosphorus Liqui-UV® 0830-125 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Iron & Total Iron Binding Capacity (TIBC) Test 0370-110 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Gamma-GT LiquiColor® 2960-500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Gamma-GT LiquiColor® 2960-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct (HDL/LDL) Cholesterol Calibrator 0595-003 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct LDL Cholesterol LiquiColor® 0710-080 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct HDL Cholesterol LiquiColor® 0590-500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct HDL Cholesterol LiquiColor® 0590-080 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct HDL Cholesterol LiquiColor® 0590-040 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Cholesterol LiquiColor® 1010-225 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Cholesterol LiquiColor® 1010-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | TDM/B-Hydroxybutyrate Linearity Standards 2450-604 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | AST/SGOT Liqui-UV® 2920-500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | AST/SGOT Liqui-UV® 2920-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | ALT/SGPT Liqui-UV® 2930-500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | ALT/SGPT Liqui-UV® 2930-430 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Albumin LiquiColor® 0285-500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site M Hgb Code Key 901010 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site M Hgb Analyzer Pack 900900 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site Diluent 202000 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site Linearity Check 303500 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site B-HB Controls 303000 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site M B-HB Strips 401010 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | STAT-Site M B-HB Analyzer Pack 400400 | 2018-04-16 |
| STANBIO LABORATORY, L.P. | Direct Bilirubin LiquiColor® 0245-250 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Direct Bilirubin LiquiColor® 0235-450 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Synchron® CX/LX/DX B-Hydroxybutyrate LiquiColor® B2440-180 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | B-Hydroxybutyrate LiquiColor® 2440-058 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | a-Amylase LiquiColor® 2970-430 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Alkaline Phosphatase LiquiColor® 2900-500 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Alkaline Phosphatase LiquiColor® 2900-430 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Acetaminophen Liquicolor® 2400-060 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | n•x•t Microcuvette 3025-050 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Uri-Trak 120 Analyzer G1200-001 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | Uri-Chek 10SG Strips 1280-100 | 2018-03-29 |
| STANBIO LABORATORY, L.P. | RELY® H.Pylori 6300-020 | 2018-03-29 |