FDA UDI
In Commercial Distribution
🇺🇸 United States
AESKULISA® ß2-Glyco-A
DI: 04250289503075
·
Model: 7205US
·
Aesku.Diagnostics GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AESKULISA® ß2-Glyco-A
- Primary DI
- 04250289503075
- Version / Model
- 7205US
- Catalog Number
- 7205US
- Company Name
- Aesku.Diagnostics GmbH & Co. KG
- Labeler DUNS
- 341714388
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 803d45f3-f428-45a8-b3fb-9fe641af702b
Device Description
AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 | 04250289503075 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062217 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius