FDA UDI
In Commercial Distribution
🇺🇸 United States
CERTUM One Step Multi-Line Drug Screen EZ Split
DI: 00810124272975
·
Model: DBO-167-022-a
·
Alere San Diego, Inc.
Product Codes
6
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- CERTUM One Step Multi-Line Drug Screen EZ Split
- Primary DI
- 00810124272975
- Version / Model
- DBO-167-022-a
- Catalog Number
- 4565161326
- Company Name
- Alere San Diego, Inc.
- Labeler DUNS
- 194854949
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2024-10-10
- Public Version
- 2
- Public Version Date
- 2026-03-13
- Public Version Status
- Update
- Public Device Record Key
- 8b09238e-d00b-44ac-957b-5be59507e9bc
Device Description
<COC300>+<AMP1000>+< mAMP1000>+<THC50>+<OPl2000> +<BZO300>
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | 862.3250 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | 862.3100 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | 862.3610 | 2 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | 862.3870 | 2 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | 862.3650 | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | 862.3170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46994 | Multiple drugs of abuse IVD, kit, rapid ICT, clinical | A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10810124272972 | GS1 | ||||
| Primary | 00810124272975 | GS1 |