FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM
DI: 08426950496984
·
Model: 0009802016
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HemosIL AcuStar Anti-B2 Glycoprotein-I IgM
- Primary DI
- 08426950496984
- Version / Model
- 0009802016
- Catalog Number
- 0009802016
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 7
- Public Version Date
- 2023-10-23
- Public Version Status
- Update
- Public Device Record Key
- f3d49434-7ece-4143-9b32-42374510912f
Device Description
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | Immunology | 866.5660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54874 | Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple classes of antibodies to cardiolipin-B2-glycoprotein I complex in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950496984 | GS1 |
Customer Contacts
- Phone
- 18006780710
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagents and calibrators are stable until the expiration date shown on the cartridge and tube labels when stored at 2-8°C