Immunodiagnostic Systems Ltd. (manufacturer, Boldon Colliery Durham, GB): 4 new FDA device listings, incl. extractable antinuclear antibody, antigen and control
Immunodiagnostic Systems Ltd. (Boldon Colliery Durham): 4 new FDA device listings, incl. extractable antinuclear antibody, antigen and control. Its amount of 4 is above the median of 1 (83rd percentile). Dated 62 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, 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: 4 · 83th percentile of 2,570 DeviceEstablishmentPulse records · 4.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 65 related GB DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Immunodiagnostic Systems Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Boldon Colliery Durham, GB |
| New listings | 4 |
| Devices | Extractable Antinuclear Antibody, Antigen And Control; Anti-Ss-A Ro60 Autoantibodies; Anti-Ss-A 52 Autoantibodies; Radioimmunoassay, Estradiol |
| Product codes | LLL, PET, OBE, CHP |
| Device classes | Class I, Class II |
| Medical specialties | Immunology, Clinical Chemistry |
| Brand names | IDS SS-A/Ro; IDS SS-A/RO 60 kDa; IDS SS-B/La; IDS High Sensitive Estradiol; IDS Estradiol |
| First new listing | 2026-06-24 |
| Latest new listing | 2026-09-04 |
| FDA registration number | 8021924 |
| Registration expires | 2026-12-31 |
| amount percentile | 83th of 2,570 (median 1, 4.0x median) |
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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: 2026-09-04
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Immunodiagnostic Systems Ltd. and 66 GB peers
- GB DeviceEstablishmentPulse records like this one: 66
- Immunodiagnostic Systems Ltd.'s amount: 83rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every GB peer: $13,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 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.
What is the DeviceEstablishmentPulse record for Immunodiagnostic Systems Ltd. in Boldon Colliery Durham?
Immunodiagnostic Systems Ltd. (Boldon Colliery Durham, GB), a manufacturer, added 4 FDA device listings between 2026-06-24 and 2026-09-04.
How does Immunodiagnostic Systems Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 4 sits in the upper half (83th percentile) of 2,570 records; the median is 1. It is 62 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Immunodiagnostic Systems Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Immunodiagnostic Systems Ltd. | Boldon Colliery Durham, GB | 4 | 83rd | 2026-09-04 |
| Piraeus Medical, Inc. | Maple Grove, MN | 4 | 83rd | 2026-10-12 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
| Beacon Biosignals, Inc. | Boston, MA | 3 | 77th | 2026-10-16 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.