| 469 | Single (specified) Analyte Controls (assayed And Unassayed) | Quality Control Material (assayed And Unassayed). |
| 469 | Single (specified) Analyte Controls (assayed And Unassayed) | Quality Control Material (assayed And Unassayed). |
| Single (Specified) Analyte Controls (Assayed And Unassayed) [34731] | 21 CFR §862.1660 🔎 |
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics |
| K162514 | Multichem A1c | Technopath Manufacturing |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | AALTO SCIENTIFIC, LTD. |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin Inc. |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin Inc. |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K152117 | Dropper HsCRP High Sensitivity CRP Control | Quantimetrix Corporation |
| K151742 | Contour Next Control Solution | BAYER HEALTHCARE |
| K150955 | Elecsys Progesterone III Cal Check 5 | ROCHE DIAGNOSTICS |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K143680 | ADVIA Centaur IgE Master Curve Material | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| K143639 | IMMULITE 2000 CEA Calibration Verification Material | Siemens Healthcare Diagnostics |
| 00389167262101 | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 00389154000549 | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 00389154000716 | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 00389154000495 | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 20385543764027 | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| 00385480547901 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480528559 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480475549 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480475532 | Single (specified) analyte controls (assayed and unassayed) |
| 10385480467992 | Single (specified) analyte controls (assayed and unassayed) |
| 10385480458860 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480440370 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480439237 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480439220 | Single (specified) analyte controls (assayed and unassayed) |
| 00385480439213 | Single (specified) analyte controls (assayed and unassayed) |
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| BIOPLEX 2200 | BIO-RAD LABORATORIES, INC | 2020-02-04 |
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| ROM PLUS RUPTURE MEMBRANES TEST | CLINICAL INNOVATIONS, LLC | 2019-11-21 |
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