Medical device manufacturer
Inova Diagnostics Incorporated
Inova Diagnostics Incorporated holds 136 FDA 510(k) clearances across 41 product codes. Median elapsed review time is 93 days. openFDA lists 4 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 136
- Product codes
- 41
- Median review
- 93 days
- Recall records
- 4
How does FDA spell Inova Diagnostics Incorporated?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| INOVA DIAGNOSTICS, INC. | device/registrationlisting | normalised |
| Inova Diagnostics Incorporated | device/enforcement | normalised |
| Inova Diagnostics Incorporated | device/recall | normalised |
| Inova Diagnostics, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Inova Diagnostics Incorporated file in?
41 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 37 | 71 days | |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 12 | 98 days | |
| MID | System, Test, Anticardiolipin Immunological | 9 | 218 days | |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 8 | 107 days | |
| MST | Antibodies, Gliadin | 8 | 93 days | |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 7 | 82 days | |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 4 | 27 days | |
| DHR | System, Test, Rheumatoid Factor | 4 | 62 days | |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 4 | 96 days | |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 163 days | |
| LSR | Reagent, Borrelia Serological Reagent | 3 | 141 days | |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 69 days | |
| JZO | System, Test, Thyroid Autoantibody | 2 | 32 days | |
| LYR | Helicobacter Pylori | 2 | 86 days | |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | 2 | 111 days | |
| NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 | 2 | 81 days | |
| NXO | Calprotectin, Fecal | 2 | 186 days | |
| OBE | Anti-Ss-A 52 Autoantibodies | 2 | 127 days | |
| DAS | Igg (Fc Fragment Specific), Antigen, Antiserum, Control | 1 | 87 days | |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 65 days | |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 | 45 days | |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 36 days | |
| KTL | Anti-Dna Indirect Immunofluorescent Solid Phase | 1 | 423 days | |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 | 269 days | |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 | 235 days |
Showing the 25 they file in most, of 41.
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 Inova Diagnostics Incorporated had a recall?
openFDA lists 4 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1221-2018Class IITerminatedJJE
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Z-1222-2018Class IITerminatedJJE
The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
Z-0280-2012TerminatedDHN
The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume.
Z-1942-2010TerminatedDAK
The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".
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 Inova Diagnostics Incorporated cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K243979 | Aptiva APS IgA Reagent | MSV | 410 | |
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | MID | 809 | |
| K213403 | Aptiva CTD Essential Reagent | LLL | 711 | |
| K200230 | Aptiva Celiac Disease IgG Reagent | MVM | 574 | |
| K193604 | Aptiva Celiac Disease IgA Reagent | MVM | 541 | |
| K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | KTL | 423 | |
| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | DHR | 90 | |
| K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | NXO | 186 | |
| K180975 | QUANTA Flash HMGCR Reagents | LLL | 73 | |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | NXO | 263 |
Source: openFDA device/510k · retrieved
Where is Inova Diagnostics Incorporated registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Inova Diagnostics Incorporated files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.