Identity
- Trade Name
- Pointe Benzodiazepine Reagent Set FDA UDI
- Generic Name
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Pointe Benzodiazepine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Benzodiazepine Reagent Set is intended for the qualitative and semi-quantitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL or 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
- Model / Reference
- 60-BZ0260-1L FDA UDI
- Description
- Pointe Benzodiazepine Reagent Set 1 x 1000 mL R1, 1 x 375 mL R2 The Pointe Benzodiazepine Reagent Set is intended for the qualitative and semi-quantitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL or 300 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. FDA UDI
Identifiers
- Catalog Number
- 60-BZ0260-1L FDA UDI
- Primary DI / UDI-DI
- 00811727017116 FDA UDI
- 510(k) Number
- K032365 FDA UDI
- FDA Product Code
- JXM FDA UDI
- GMDN Term
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3170 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: Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)
Pointe Benzodiazepine Reagent Set by Pointe Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Benzodiazepine group IVD, kit, enzyme immunoassay (EIA).
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- CAROLINA LIQUID CHEMISTRIES CORP.® BENZ RGT KIT Product No. DT418 — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K032365 also covers:
- Benzodiazepine DAU Calibrator, Calibrator #5 — Lin-Zhi International, Inc.
- Benzodiazepine DAU Calibrator/Control, Calibrator #2/Control 1 — Lin-Zhi International, Inc.
- Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 — Lin-Zhi International, Inc.
- Benzodiazepine DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 — Lin-Zhi International, Inc.
- Benzodiazepine DAU Control , Control 4 — Lin-Zhi International, Inc.
- Benzodiazepine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Benzodiazepine Enzyme Immunoassay — Lin-Zhi International, Inc.
- Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Benzodiazepine Calibrator/Control (Oxazepam 100 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Benzodiazepine Calibrator/Control (Oxazepam 200 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL) — POINTE SCIENTIFIC, INC.
- Pointe Benzodiazepine Control (Oxazepam 400 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pointe Scientific, Inc.
Sources (1)
- FDA UDI 75583b43-6995-4803-bde1-8fdcf0dd2de8 37 fields · synced May 30, 2026