Side-by-side comparison
| Attribute | TestOxidase PL.390 | Lab-prepared TMPD | Hardy OxiDrop Z119 |
|---|
| Shelf life | 9 months from manufacture | ~24 hours after preparation | Per IFU |
| Storage | 15–30°C (room temperature) | 2–8°C refrigerated | 2–8°C refrigerated |
| Read window | 30 seconds | Variable — preparation-dependent | 10 seconds (per Hardy IFU) |
| Regulatory | CE IVD, ISO 13485 / MDSAP, FDA Class I Exempt (21 CFR 866.2660, JTO) | No IVD documentation | CE IVD |
| Cold chain freight required | No | N/A (in-house) | Yes |
| Tests per 15 mL bottle | 350–400 | Variable | Per Hardy specifications |
| Direct list price | $51.10 (PL.390, 15 mL) | Reagent + tech time | Per distributor |
Three operational implications
1. Cold-chain compliance overhead is eliminated. Room-temperature storage means no refrigerator monitoring log entry, no temperature-excursion deviation report, and no cold-pack receiving inspection — for a daily-use bench reagent.
2. The 30-second read window matters at high volume. A 10-second window forces a single tech to focus on a single test; a 30-second window lets one tech read multiple plates in series without missing a positive that develops late.
3. CAP/CLIA documentation is included in the SKU. Lab-prepared TMPD requires you to author and maintain a reagent prep SOP, log every batch, and document validation. PL.390’s ISO 13485 / MDSAP and CE IVD documentation satisfies the IVD record your accreditor expects — out of the box.
Shared limitation, disclosed honestly
Both TestOxidase PL.390 and Hardy OxiDrop Z119 IFUs flag variable results with Haemophilus. Neither product resolves that limitation. If your workflow includes Haemophilus identification, follow your existing confirmatory protocol regardless of oxidase reagent choice.
Need pricing on PL.390-125 (125 mL bulk) or a CAP-ready vendor packet (ISO 13485 cert, CE declaration, IFU)? Reply and we will send same business day.
View this document online: https://www.pro-lab-direct.com/testoxidase/deliverables/comparison-guide.html
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