Inova Diagnostics, Inc. (manufacturer, San Diego, CA): 3 new FDA device listings, incl. system, test, anticardiolipin immunological
Inova Diagnostics, Inc. (San Diego, California): 3 new FDA device listings, incl. system, test, anticardiolipin immunological. Its amount of 3 is above the median of 2 (77th percentile). Dated 135 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 3 · 77th percentile of 2,709 DeviceEstablishmentPulse records · 1.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 309 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Inova Diagnostics, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Repack or Relabel Medical Device |
| Location | San Diego, CA, US |
| New listings | 3 |
| Devices | System, Test, Anticardiolipin Immunological; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); System, Multipurpose For In Vitro Coagulation Studies |
| Product codes | MID, MSV, JPA |
| Device classes | Class II |
| Medical specialties | Immunology, Hematology |
| Brand names | Aptiva APS IgA Reagent; BIO-FLASH Screw Caps for Sample Cups; BIO-FLASH Sample Racks Adapters; BIO-Flash Sample Racks; BIO-FLASH High Capacity Rinse Accessory; BIO-FLASH Waste Bottle; BIO-FLASH Triggers; BIO-FLASH |
| First new listing | 2026-06-09 |
| Latest new listing | 2026-06-23 |
| FDA registration number | 2026994 |
| Registration expires | 2026-12-31 |
| amount percentile | 77th of 2,709 (median 2, 1.5x median) |
| Peer records CSV (310 CA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-06-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (CA first): Icu Medical, Inc. (specification developer, San Clemente, CA · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Innopex Limited (foreign exporter, Toronto Ontario, CA) · Citest Diagnostics Inc. (repackager or relabeler, VANCOUVER · Cgbio USA, Inc. (repackager or relabeler, Irvine, CA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Inova Diagnostics, Inc. and 310 California peers
- California DeviceEstablishmentPulse records like this one: 310
- Inova Diagnostics, Inc.'s amount: 77th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $62,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Inova Diagnostics, Inc. in San Diego, California?
Inova Diagnostics, Inc. (San Diego, CA), a manufacturer, added 3 FDA device listings between 2026-06-09 and 2026-06-23.
How does Inova Diagnostics, Inc. compare to other California DeviceEstablishmentPulse records?
Its amount of 3 sits in the upper half (77th percentile) of 2,709 records; the median is 2. It is 135 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Inova Diagnostics, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date | Compare |
|---|---|---|---|---|---|
| Inova Diagnostics, Inc. | San Diego, CA | 3 | 77th | 2026-06-23 | This record |
| Applied Medical Resources Corp. | Rsm, CA | 3 | 77th | 2026-10-23 | Compare Inova Diagnostics, Inc. vs Applied Medical Resources Corp. → |
| Intuitive Surgical, Inc. | Sunnyvale, CA | 13 | 95th | 2026-10-22 | View record → |
| Intuitive Surgical, Inc. | Santa Clara, CA | 13 | 95th | 2026-10-22 | View record → |
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DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in California
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.