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Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2 FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
- Device Name
- Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 300 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) on automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-MM0396-5 FDA UDI
- Description
- Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2 1 x 5 mL The Pointe Methadone Metabolite (EDDP) 300 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Methadone Metabolite (EDDP) Reagent Set (Ref# 60-MM0380-100/60-MM0380-1L) on automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-MM0396-5 FDA UDI
- Primary DI / UDI-DI
- 00811727018205 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, control
Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2 by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control.
- Methadone Metabolite 100 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- EDDP CONTROL 2 — Randox Laboratories, Ltd. · Class I
- Methadone Metabolite 300 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Methadone Metabolite DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class II
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI b3553547-1485-4117-8e40-c0ce44a0922f 36 fields · synced May 30, 2026