Identity
- Trade Name
- Pointe Hydrocodone 100 Calibrator (300 ng/mL) FDA UDI
- Generic Name
- Multiple drugs of abuse IVD, calibrator FDA UDI
- Device Name
- Pointe Hydrocodone 100 Calibrator (300 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-HY0770-5 FDA UDI
- Description
- Pointe Hydrocodone 100 Calibrator (300 ng/mL) 1 x 5 mL The Pointe Hydrocodone 100 Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the Pointe Hydrocodone 100 Reagent Set (Ref# 60-HY0760-100/60-HY0760-1L) on a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-HY0770-5 FDA UDI
- Primary DI / UDI-DI
- 00811727016744 FDA UDI
- 510(k) Number
- K141055 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Multiple drugs of abuse IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3200 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: Multiple drugs of abuse IVD, calibrator
Pointe Hydrocodone 100 Calibrator (300 ng/mL) by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141055 also covers:
- Pointe Hydrocodone 100 Calibrator (100 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Calibrator (150 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Calibrator (50 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Level 1 Control (75 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Level 2 Control (125 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Reagent Set — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 100 Reagent Set — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 300 Calibrator (150 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 300 Calibrator (300 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 300 Calibrator (500 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 300 Calibrator (800 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Hydrocodone 300 Level 1 Control (225 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 7a3e83ad-62bb-4a28-8a33-795ab1f44c19 37 fields · synced Jun 8, 2026