Product Code: DPG
FDA class 2
21 CFR 862.3300
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Clinical Toxicology
The Radioimmunoassay for Digitoxin using iodine-125 with rabbit antibody and coated tube separation is a laboratory test system that measures digitoxin in patient serum using a solid-phase coated-tube radioimmunoassay format with iodine-125 tracer and rabbit-derived antibodies. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPG, regulated under 21 CFR 862.3300, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
16
Basic Information
- Product Code
- DPG
- Device Class
- FDA class 2
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K935229 | OPUS DIGITOXIN | Dec 22, 1993 | Substantially Equivalent | Pb Diagnostic Systems, Inc. |
| K812129 | COAT-A-COUNT DIGITOXIN RIA KIT | Aug 13, 1981 | Substantially Equivalent | Diagnostic Products Corp. |
| K780075 | RIALYZE DIGOXIN | Feb 28, 1978 | Substantially Equivalent | Miles Laboratories, Inc. |