FDA product code GIZ: Plasma, Control, Normal
GIZ is the FDA product code for plasma, control, normal. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel. FDA has cleared 20 510(k) submissions under GIZ, from 15 different applicants. The average 510(k) review took 117 days (median 42). FDA has posted 1 recall for GIZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Plasma, Control, Normal |
| Device class | Class II |
| Regulation | 21 CFR 864.5425 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Top GIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 3 | 2004-12-02 |
| Sigma Diagnostics, Inc. | 2 | 2001-03-01 |
| Medical Diagnostic Technologies, Inc. | 2 | 1990-12-28 |
| Analytical Control Systems, Inc. | 2 | 1989-06-23 |
| Wortham Laboratories, Inc. | 1 | 2007-05-15 |
10 more applicants have GIZ clearances. See the full list in Caduvo.
Most recent GIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060968 | Wortham Laboratories, Inc. | STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW | 2007-05-15 | 403 |
| K042941 | Dade Behring, Inc. | DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS | 2004-12-02 | 38 |
| K023309 | Dade Behring, Inc. | CONTROL PLASMA N | 2002-11-01 | 29 |
| K013708 | Precision Biologic | REFERENCE CHECK, CATALOG NUMBER-RCN-10 | 2001-12-10 | 32 |
| K003328 | Sigma Diagnostics, Inc. | ACCUCLOT CONTROL I, MODEL A4089 | 2001-03-01 | 128 |
Recalls for GIZ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code GIZ?
GIZ is the FDA product code for plasma, control, normal. It is a Class II device, regulated under 21 CFR 864.5425 and reviewed by the Hematology panel.
What device class is GIZ?
Class II, regulation 21 CFR 864.5425. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GIZ?
Across 20 cleared submissions the average was 117 days from receipt to decision (median 42).
Which companies have the most GIZ clearances?
Dade Behring, Inc. (3); Sigma Diagnostics, Inc. (2); Medical Diagnostic Technologies, Inc. (2); Analytical Control Systems, Inc. (2); Wortham Laboratories, Inc. (1).
Have GIZ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2019-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GIZ
- Run a recall and safety report across every GIZ manufacturer
- Watch product code GIZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.