Identity
- Trade Name
- Pointe Amphetamines 500 Reagent Set FDA UDI
- Generic Name
- Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-AM0200-100 FDA UDI
- Description
- Pointe Amphetamines 500 Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Amphetamines 500 Reagent Set is intended for the qualitative and semi-quantitative determination of methamphetamine and amphetamine in human urine at a cutoff value of 500 ng/mL when calibrated with d-methamphetamine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-AM0200-100 FDA UDI
- Primary DI / UDI-DI
- 00811727016539 FDA UDI
- 510(k) Number
- K102210 FDA UDI
- FDA Product Code
- DKZ FDA UDI
- GMDN Term
- Amphetamine-specific IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3100 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: Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
Pointe Amphetamines 500 Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Amphetamine-specific IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
K102210 also covers:
- Amphetamines 500 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Amphetamines 500 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Amphetamines 500 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) — 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 0db2b28e-a9ee-41c3-9811-e4e082086745 37 fields · synced May 30, 2026