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Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, control FDA UDI
- Device Name
- Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 1 x 5 mL The Pointe 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-AC0596-5 FDA UDI
- Description
- Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 1 x 5 mL The Pointe 6-Acetylmorphine Controls are for use as assayed quality control materials to monitor the precision of the Pointe 6-Acetylmorphine Reagent Set (Ref# 60-AC0580-100/60-AC0580-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-AC0596-5 FDA UDI
- Primary DI / UDI-DI
- 00811727018298 FDA UDI
- 510(k) Number
- K101195 FDA UDI
- FDA Product Code
- LAS FDA UDI
- GMDN Term
- 6-Acetyl morphine 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: 6-Acetyl morphine IVD, control
Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2 by Pointe Scientific, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 6-Acetyl morphine IVD, control.
- Oral Fluid 6-Acetylmorphine Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- 6-Acetylmorphine DAU Control, Level 2 Control — Lin-Zhi International, Inc. · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- Immunalysis — Immunalysis Corporation · Class I
- 6-Acetylmorphine DAU Control, Level 1 Control — Lin-Zhi International, Inc. · Class I
- Oral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control — Lin-Zhi International, Inc. · Class I
- 6-Acetylmorphine Control Set — Lin-Zhi International, Inc. · Class I
Cleared under the same submission
K101195 also covers:
- Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Reagent Set — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Reagent Set — 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 59243e64-2cda-4fc3-bb8d-793d5dcbd5cc 37 fields · synced May 31, 2026