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Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL) FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, control FDA UDI
- Device Name
- Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL) 1 x 5 mL The Pointe Opiates 2000 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Opiates 2000 Reagent Set (Ref# 60-OP0660-100/60-OP0660-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-OP0674-5 FDA UDI
- Description
- Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL) 1 x 5 mL The Pointe Opiates 2000 Controls are for use as assayed quality control materials to monitor the precision of the Pointe Opiates 2000 Reagent Set (Ref# 60-OP0660-100/60-OP0660-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-OP0674-5 FDA UDI
- Primary DI / UDI-DI
- 00811727017000 FDA UDI
- 510(k) Number
- K120761 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- Opiate/opiate 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: Opiate/opiate metabolite IVD, control
Pointe Opiates 2000 Level 1 Control (Morphine 1500 ng/mL) by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Opiate/opiate metabolite IVD, control.
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- Opiate 2000 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Opiate 2000 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Hydrocodone 300 DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Hydrocodone 100 DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K120761 also covers:
- Opiate 2000 DAU Calibrator, Cutoff Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Calibrator, High Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Calibrator, Intermediate Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Calibrator, Low Calibrator — Lin-Zhi International, Inc.
- Opiate 2000 DAU Control, Level 1 Control — Lin-Zhi International, Inc.
- Opiate 2000 DAU Control, Level 2 Control — Lin-Zhi International, Inc.
- Opiate 2000 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Opiate 2000 Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Opiates 2000 Calibrator (Morphine 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 4000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Opiates 2000 Calibrator (Morphine 6000 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 a10c7517-c4e5-4b97-aad5-516b6179dbec 37 fields · synced May 30, 2026