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Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL) FDA UDI
- Generic Name
- Cocaine/cocaine metabolite IVD, control FDA UDI
- Device Name
- Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL) 1 x 5 mL The Pointe Cocaine Metabolite 150 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cocaine Metabolite 150 Reagent Set (Ref# 60-CC0680-100/60-CC0680-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-CC0696-5 FDA UDI
- Description
- Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL) 1 x 5 mL The Pointe Cocaine Metabolite 150 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Cocaine Metabolite 150 Reagent Set (Ref# 60-CC0680-100/60-CC0680-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-CC0696-5 FDA UDI
- Primary DI / UDI-DI
- 00811727017901 FDA UDI
- 510(k) Number
- K113139 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Cocaine/cocaine metabolite 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
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: Cocaine/cocaine metabolite IVD, control
Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL) by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cocaine/cocaine metabolite IVD, control.
- Cocaine Metabolite 150 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Cocaine Metabolite DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Cocaine Metabolite 150 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Cocaine Metabolite DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- COCAINE PLUS 800 NG/ML — UTAK LABORATORIES, INC. · Class I
- Pointe Cocaine Level 2 Control (BE 375 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Pointe Cocaine Metabolite 150 Level 1 Control (BE 112.5 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Pointe Cocaine Level 1 Control (BE 225 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
Cleared under the same submission
K113139 also covers:
- Cocaine Metabolite 150 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Cocaine Metabolite 150 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Cocaine Metabolite 150 Calibrator (BE 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Cocaine Metabolite 150 Calibrator (BE 150 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Cocaine Metabolite 150 Calibrator (BE 300 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Cocaine Metabolite 150 Calibrator (BE 75 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI f83d9295-d47f-4c6d-87d2-4e5a3813782d 37 fields · synced May 30, 2026