Identity
- Trade Name
- Benzodiazepine Enzyme Immunoassay FDA UDI
- Generic Name
- Benzodiazepine group IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. FDA UDI
- Model / Reference
- 0131 FDA UDI
- Description
- Large Test Kit. Antibody/Substrate Reagent (R1): 1000 mL. Enzyme Conjugate Reagent (R2): 375 mL. FDA UDI
Identifiers
- Catalog Number
- 0131 FDA UDI
- Primary DI / UDI-DI
- B07601310 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)
Benzodiazepine Enzyme Immunoassay by Lin-Zhi International, 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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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.
- 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.
- Pointe Benzodiazepine 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 |
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Manufacturer
- Manufacturer
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 7e29fee8-734d-49f9-9615-72016e6e728b 36 fields · synced Jun 9, 2026