Identity
- Trade Name
- Pointe Methadone Metabolite (EDDP) Reagent Set FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MM0380-100 FDA UDI
- Description
- Pointe Methadone Metabolite (EDDP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Methadone Metabolite (EDDP) Reagent Set is an in vitro diagnostic test intended for the qualitative and semi-quantitative determination of methadone metabolite in human urine. The cutoff for both the qualitative and semi-quantitative modes of the assay are 100 ng/mL and 300 ng/mL for methadone metabolite. The assay is designed for prescription use on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MM0380-100 FDA UDI
- Primary DI / UDI-DI
- 00811727018076 FDA UDI
- 510(k) Number
- K031797 FDA UDI
- FDA Product Code
- DJR FDA UDI
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA)
Pointe Methadone Metabolite (EDDP) Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, kit, enzyme immunoassay (EIA).
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- Immunalysis — Immunalysis Corporation · Class II
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- Methadone Metabolite Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
Cleared under the same submission
K031797 also covers:
- Methadone Metabolite DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Methadone Metabolite DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Methadone Metabolite DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Methadone Metabolite DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Methadone Metabolite DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Methadone Metabolite DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Methadone Metabolite Enzyme Immunoassay — Lin-Zhi International, Inc.
- Methadone Metabolite Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff — POINTE SCIENTIFIC, INC.
- Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High — POINTE SCIENTIFIC, INC.
- Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low — POINTE SCIENTIFIC, INC.
- Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate — POINTE SCIENTIFIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 40748fcf-e432-4d3a-a494-78ef4500c6ce 37 fields · synced May 31, 2026