Medical device manufacturer
Behring Diagnostics, Inc.
Behring Diagnostics, Inc. holds 145 FDA 510(k) clearances across 80 product codes. Median elapsed review time is 70 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 145
- Product codes
- 80
- Median review
- 70 days
- Recall records
- 0
How does FDA spell Behring Diagnostics, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Behring Diagnostics, Inc. file in?
80 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 7 | 27 days | |
| DHR | System, Test, Rheumatoid Factor | 5 | 52 days | |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 | 136 days | |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 5 | 75 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 58 days | |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 5 | 106 days | |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 5 | 192 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 25 days | |
| JZW | Nephelometer | 4 | 20 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 26 days | |
| DDR | Myoglobin, Antigen, Antiserum, Control | 3 | 23 days | |
| GGC | Control, Plasma, Abnormal | 3 | 540 days | |
| GJT | Plasma, Coagulation Factor Deficient | 3 | 263 days | |
| GTQ | Antistreptolysin - Titer/Streptolysin O Reagent | 3 | 160 days | |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 3 | 203 days | |
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | 2 | 36 days | |
| CIJ | Saccharogenic, Amylase | 2 | 15 days | |
| CZW | Complement C3, Antigen, Antiserum, Control | 2 | 41 days | |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 40 days | |
| DCF | Albumin, Antigen, Antiserum, Control | 2 | 10 days | |
| DCN | System, Test, C-Reactive Protein | 2 | 9 days | |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 36 days | |
| GFO | Activated Partial Thromboplastin | 2 | 142 days | |
| GGN | Plasma, Coagulation Control | 2 | 92 days | |
| GIL | Plasma, Fibrinogen Control | 2 | 38 days |
Showing the 25 they file in most, of 80.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Behring Diagnostics, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Behring Diagnostics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K973832 | OPUS HLH CONTROLS | JJX | 20 | |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | DCF | 73 | |
| K972840 | N ANTISERUM TO HUMAN TRANSFERRIN | DDG | 77 | |
| K973202 | MODIFICATION OF OPUS FERRITIN TEST SYSTEM | DBF | 66 | |
| K972316 | OPUS D-DIMER | GHH | 81 | |
| K972116 | VON WILLEBRAND REAGENT | GGP | 50 | |
| K972011 | OPUS ETHANOL | DIC | 53 | |
| K971600 | EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) | DKB | 55 | |
| K971596 | EMIT II OPIATES 300/2000 ASSAY | DJG | 55 | |
| K964595 | OPUS PSA TEST SYSTEM | LTJ | 218 |
Source: openFDA device/510k · retrieved
Watch what Behring Diagnostics, Inc. files next
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