FDA UDI
In Commercial Distribution
🇺🇸 United States
Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2
DI: B07601330
·
Model: 0133
·
LIN-ZHI INTERNATIONAL, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Benzodiazepine DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2
- Primary DI
- B07601330
- Version / Model
- 0133
- Catalog Number
- 0133
- Company Name
- LIN-ZHI INTERNATIONAL, INC.
- Labeler DUNS
- 840839190
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-05
- Public Version
- 4
- Public Version Date
- 2018-08-24
- Public Version Status
- Update
- Public Device Record Key
- 35f87478-e7ae-4ff8-b005-739fe33537e8
Device Description
5mL/bottle. Concentration: 200 ng/mL of Oxazepam.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LAS | Drug Specific Control Materials | Clinical Toxicology | 862.3280 | 1 |
| DLJ | Calibrators, Drug Specific | Clinical Toxicology | 862.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55526 | Benzodiazepine group IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen. | No | Active |
| 55527 | Benzodiazepine group IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of one or multiple benzodiazepines in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B07601330 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K032365 | 000 |