Tetrabromo-M-Cresolsulfonphthalein, Albumin
The Tetrabromo-M-Cresolsulfonphthalein (Bromcresol Purple), Albumin test system (product code CJG) is an in-vitro diagnostic device used in clinical chemistry to measure albumin concentrations in serum using the bromcresol purple (BCP) dye-binding colorimetric method, which is considered more specific than bromcresol green for albumin in some patient populations. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1035 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CJG
- Device Class
- FDA class 2
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K972706 | CLINITEK MICROALBUMIN REAGENT STRIPS | Sep 09, 1997 | Substantially Equivalent | Bayer Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.