Identity
- Trade Name
- Hydrocodone 100 Semi-Quantitative Calibrators Set FDA UDI
- Generic Name
- Opiate/opiate metabolite IVD, calibrator FDA UDI
- Device Name
- HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 100 Low Calibrator 50 ng/mL (1 x 5 mL), HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL), HYD 100 Intermediate Calibrator 150 ng/mL (1 x 5 mL), HYD 100 High Calibrator 300 ng/mL (1 x 5 mL). FDA UDI
- Model / Reference
- 08304718190 FDA UDI
- Description
- HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL), HYD 100 Low Calibrator 50 ng/mL (1 x 5 mL), HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL), HYD 100 Intermediate Calibrator 150 ng/mL (1 x 5 mL), HYD 100 High Calibrator 300 ng/mL (1 x 5 mL). FDA UDI
Identifiers
- Catalog Number
- 08304718190 FDA UDI
- Primary DI / UDI-DI
- 00850624008155 FDA UDI
- FDA Product Code
- DLJ FDA UDI
- GMDN Term
- Opiate/opiate metabolite 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: Opiate/opiate metabolite IVD, calibrator
Hydrocodone 100 Semi-Quantitative Calibrators Set by Lin-Zhi International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Opiate/opiate metabolite IVD, calibrator.
- Immunalysis — Immunalysis Corporation · Class II
- Immunalysis — Immunalysis Corporation · Class II
- ARK™ Fentanyl Negative Calibrator (WPT) — ARK DIAGNOSTICS INC · Class II
- Immunalysis — Immunalysis Corporation · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
- Pointe Opiates 2000 Calibrator (Morphine 2000 ng/mL) — POINTE SCIENTIFIC, INC. · Class II
- Rapid ONE — American Bio Medica Corp. · U
- Immunalysis — Immunalysis Corporation · Class II
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
- Lin-Zhi International, Inc.
Sources (1)
- FDA UDI 53f88efd-2c2c-4b70-9bbc-40cb7331da45 35 fields · synced Jun 9, 2026