Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen
The Ion-Exchange Resin, Ehrlich's Reagent, Porphobilinogen test is a clinical chemistry diagnostic device used to detect and measure porphobilinogen in urine, a compound relevant to the diagnosis of acute porphyrias. The colorimetric reaction uses Ehrlich's reagent following ion-exchange resin separation to identify the analyte. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JNF and is regulated under 21 CFR 862.1590, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JNF
- Device Class
- FDA class 1
- Regulation Number
- 862.1590
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961984 | PORPHOBILINOGEN (PBG) | Dec 10, 1996 | Substantially Equivalent | Trace America, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.