FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL AcuStar Anti-B2GPI Domain 1 Controls
DI: 08426951301706
·
Model: 00009800022
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- Primary DI
- 08426951301706
- Version / Model
- 00009800022
- Catalog Number
- 00009800022
- Company Name
- INSTRUMENTATION LABORATORY COMPANY
- Labeler DUNS
- 557223252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2018-07-17
- Public Version
- 3
- Public Version Date
- 2021-07-14
- Public Version Status
- Update
- Public Device Record Key
- 6aec0b80-174d-4adc-a0f8-c47e9d0c1579
Device Description
1. HemosIL Acustar ß2GP1-Domain1 Low Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives. 2. HemosIL Acustar ß2GP1-Domain1 High Control, containing: 3 x 1 mL barcoded tubes of a solution with human antibodies to ß2GP1-Domain1 in buffer, stabilizers, and preservatives.
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| JJX | Single (specified) analyte controls (assayed and unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41276 | Beta-2-glycoprotein I antibody 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 classes of antibodies to beta-2-glycoprotein I in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426951301706 | GS1 | ||||
| Unit of Use | 18426951301703 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152875 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stability after opening on board the ACL AcuStar System is 2.5 hours. Do not Freeze.