DeviceEstablishmentPulse / report
DRG International, Inc. (repackager or relabeler, Springfield, NJ): 13 new FDA device listings, incl. prostate-specific antigen (psa) for management of prostate cancers
DRG International, Inc. (Springfield, New Jersey): 13 new FDA device listings, incl. prostate-specific antigen (psa) for management of prostate cancers. Its amount of 13 is top-decile (95th percentile of 2,570 records). Dated 49 days ago, it serves as a historical benchmark. Score 65/100. 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: 13 · 95th percentile of 2,570 DeviceEstablishmentPulse records · 13.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 48 related NJ DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | DRG International, Inc. |
| Owner / operator | Biocheck, Inc. |
| Role | Repackager or relabeler |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device |
| Location | Springfield, NJ, US |
| New listings | 13 |
| Devices | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Antibody Igm, If, Epstein-Barr Virus; Antigen, Ebv, Capsid; Radioimmunoassay, Testosterones And Dihydrotestosterone; Helicobacter Pylori; Radioimmunoassay, Cortisol; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) |
| Product codes | LTJ, MOB, LJN, MCD, CDZ, LYR, CGR, LIP, MXJ, NHX, KTO, JHI, DBM |
| Device classes | Class I, Class II |
| Medical specialties | Immunology, Microbiology, Clinical Chemistry |
| Brand names | PSA Total; EIA-3597 pANCA (MPO) ELISA; EIA-6204 EBV (EA) IgM ELISA; EIA-3476 EBV-VCA IgM ELISA; SHBG ELISA; EIA-2111 Helicobacter pylori IgM ELISA; EIA-1887 Cortisol; EIA-4267 Treponema pallidum (Syphillis) IgM |
| First new listing | 2026-05-11 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 2245285 |
| Registration expires | 2026-12-31 |
| amount percentile | 95th of 2,570 (median 1, 13.0x median) |
| Peer records CSV (49 NJ records) | 🔒 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: 2026-09-16
- 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: DRG International, Inc. and 49 New Jersey peers
- New Jersey DeviceEstablishmentPulse records like this one: 49
- DRG International, Inc.'s amount: 95th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New Jersey peer: $9,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
65 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for DRG International, Inc. in Springfield, New Jersey?
DRG International, Inc. (Springfield, NJ), a repackager or relabeler, added 13 FDA device listings between 2026-05-11 and 2026-09-16.
How does DRG International, Inc. compare to other New Jersey DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 13 is 13.0x the median of 1 across 2,570 records. It is 49 days old; check the official source for later updates before acting.
DRG International, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| DRG International, Inc. | Springfield, NJ | 13 | 95th | 2026-09-16 |
| Karl Storz Endoscopy-America, Inc. | Auburn, MA | 14 | 96th | 2026-09-28 |
| VIVE Health LLC | Naples, FL | 10 | 93rd | 2026-10-14 |
| Tpc Advanced Technology, Inc. | City Industry, CA | 4 | 83rd | 2026-09-28 |
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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.