Identity
- Trade Name
- Methamphetamine Enzyme Immunoassay FDA UDI
- Generic Name
- Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. FDA UDI
- Model / Reference
- 0351 FDA UDI
- Description
- Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. FDA UDI
Identifiers
- Catalog Number
- 0351 FDA UDI
- Primary DI / UDI-DI
- B07603510 FDA UDI
- 510(k) Number
- K113661 FDA UDI
- FDA Product Code
- LAF FDA UDI
- GMDN Term
- Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3610 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: Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Methamphetamine Enzyme Immunoassay by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
K113661 also covers:
- Methamphetamine DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Methamphetamine DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Methamphetamine DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Methamphetamine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (2000 ng/mL) High — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (250 ng/mL) Low — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff — POINTE SCIENTIFIC, INC.
- Pointe Methamphetamine Control (375 ng/mL) Level 1 — 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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 3c27ceda-99a2-45e5-ab0b-2e9441abad2a 36 fields · synced Jun 9, 2026