Identity
- Trade Name
- Pointe 6-Acetylmorphine Reagent Set FDA UDI
- Generic Name
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe 6-Acetylmorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe 6-Acetylmorphine Reagent Set is intended for the qualitative and semi-quantitative determination of 6-acetylmorphine in human urine at a cutoff value of 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-AC0580-100 FDA UDI
- Description
- Pointe 6-Acetylmorphine Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe 6-Acetylmorphine Reagent Set is intended for the qualitative and semi-quantitative determination of 6-acetylmorphine in human urine at a cutoff value of 10 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-AC0580-100 FDA UDI
- Primary DI / UDI-DI
- 00811727018212 FDA UDI
- 510(k) Number
- K101195 FDA UDI
- FDA Product Code
- DJG FDA UDI
- GMDN Term
- 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3650 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, kit, enzyme immunoassay (EIA)
Pointe 6-Acetylmorphine Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA).
- Syva® Emit® II Plus 6-Acetylmorphine Assay — Siemens Healthcare Diagnostics · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT ST325 — Carolina Liquid Chemistries Corp. · Class I
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM RGT. KIT AU-425 — Carolina Liquid Chemistries Corp. · Class I
- Syva® Emit® II Plus 6-Acetylmorphine Assay — Siemens Healthcare Diagnostics · Class II
- 6-Acetylmorphine Enzyme Immunoassay — Lin-Zhi International, Inc. · Class II
- Immunalysis — Immunalysis Corporation · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® 6-AM REAGENT KIT Product No. DT425 — Carolina Liquid Chemistries Corp. · Class II
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 (12.5 ng/mL) Level 2 — POINTE SCIENTIFIC, INC.
- Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1 — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI f464bca2-32db-4e19-858d-55ec51f2de19 37 fields · synced May 30, 2026