Identity
- Trade Name
- Pointe Cannabinoid (THC) Reagent Set FDA UDI
- Generic Name
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only. FDA UDI
- Model / Reference
- 60-CA0140-100 FDA UDI
- Description
- Pointe Cannabinoid (THC) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Cannabinoids (THC) Reagent Set is intended for the qualitative and semi-quantitative determination of cannabinoids in human urine using 11-nor-9-THC-9-COOH, (referred to hereafter as THC). The calibrator at the cutoff has a value of 25 ng/mL, 50 ng/mL, or 100 ng/mL dependent on the chosen parameters. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS or (2) permitting laboratories to establish quality control procedures. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. These assays are for prescription use only. FDA UDI
Identifiers
- Catalog Number
- 60-CA0140-100 FDA UDI
- Primary DI / UDI-DI
- 00811727017246 FDA UDI
- 510(k) Number
- K110239 FDA UDI
- FDA Product Code
- LDJ FDA UDI
- GMDN Term
- Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3870 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: Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)
Pointe Cannabinoid (THC) Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA).
- Alinity — Abbott Laboratories, Inc. · Class II
- Dimension Vista® Flex® reagent cartridge THC — Siemens Healthcare Diagnostics · Class II
- Oral Fluid Cannabinoid Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Syva® Emit® II Plus Cannabinoid Assay — Siemens Healthcare Diagnostics · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® THC RGT KIT Product No. DT410 — Carolina Liquid Chemistries Corp. · Class II
- Atellica CH Thc — Siemens Healthcare Diagnostics · Class II
- Immunalysis — Immunalysis Corporation · Class II
Cleared under the same submission
K110239 also covers:
- Cannabinoid Enzyme Immunoassay — Lin-Zhi International, Inc.
- Cannabinoid Enzyme Immunoassay — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator, Negative Calibrator — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator/Control, Calibrator/Control — Lin-Zhi International, Inc.
- Cannabinoids DAU Calibrator/Control, Calibrator/Control — Lin-Zhi International, Inc.
- Cannabinoids DAU Control, Control — Lin-Zhi International, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 2cef5700-aee0-4efb-8bd1-23810fc820e3 37 fields · synced May 31, 2026