Identity
- Trade Name
- Methadone Metabolite 100 Control Set FDA UDI
- Generic Name
- 2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, control FDA UDI
- Device Name
- EDDP 100 Negative Control 75 ng/mL (2 x 15 mL), EDDP 100 Positive Control 125 ng/mL (2 x 15 mL). FDA UDI
- Model / Reference
- 08735620190 FDA UDI
- Description
- EDDP 100 Negative Control 75 ng/mL (2 x 15 mL), EDDP 100 Positive Control 125 ng/mL (2 x 15 mL). FDA UDI
Identifiers
- Catalog Number
- 08735620190 FDA UDI
- Primary DI / UDI-DI
- 00850624008209 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
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
Yes
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
Methadone Metabolite 100 Control Set by Lin-Zhi International, Inc. — Class I — 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, control.
- Immunalysis — Immunalysis Corporation · Class I
- EDDP CONTROL 2 — Randox Laboratories, Ltd. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Pointe Methadone Metabolite (EDDP) Control (75 ng/mL) Level 1 — POINTE SCIENTIFIC, INC. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Pointe Methadone Metabolite (EDDP) Control (125 ng/mL) Level 2 — POINTE SCIENTIFIC, INC. · Class I
- EDDP CONTROL 1 — Randox Laboratories, Ltd. · 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 061b9374-7b46-4cc3-96b1-1c6d7d599eee 35 fields · synced Jun 9, 2026