FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MULTI-PREP
DI: 00810042681682
·
Model: 14200820
·
BIOCHEMICAL DIAGNOSTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MULTI-PREP
- Primary DI
- 00810042681682
- Version / Model
- 14200820
- Catalog Number
- 14200820
- Company Name
- BIOCHEMICAL DIAGNOSTICS INC
- Labeler DUNS
- 028007698
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-15
- Public Version
- 2
- Public Version Date
- 2022-01-11
- Public Version Status
- Update
- Public Device Record Key
- 2f878f6d-187e-4089-88ba-d7192750bda3
- Distribution End Date
- 2022-01-10
Device Description
Multi-Prep® GVSA-200 SPE Columns
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
- Yes
- 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 |
|---|---|---|---|---|
| DKO | Adsorbents, Ion-Exchange | Clinical Chemistry | 862.2230 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55462 | Multiple drugs of abuse IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042681682 | GS1 |
Customer Contacts
- Phone
- 6315959200
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius