FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ABBOTT PRISM
DI: 00380740062989
·
Model: 6D19-68
·
ABBOTT LABORATORIES
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ABBOTT PRISM
- Primary DI
- 00380740062989
- Version / Model
- 6D19-68
- Catalog Number
- 06D1968
- Company Name
- ABBOTT LABORATORIES
- Labeler DUNS
- 079226220
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-01-31
- Public Version
- 6
- Public Version Date
- 2023-07-10
- Public Version Status
- Update
- Public Device Record Key
- 88694515-85ee-4f86-bed4-0d9e96f299d9
- Distribution End Date
- 2023-03-21
Device Description
ABBOTT PRISM HBsAg Assay Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48321 | Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus surface antigen in a clinical specimen, using a chemiluminescent immunoassay method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380740062989 | GS1 |
Customer Contacts
- Phone
- +1(877)422-2688
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius