FDA UDI
In Commercial Distribution
🇺🇸 United States
HemosIL Plasmin Inhibitor
DI: 08426950031734
·
Model: 00020009200
·
INSTRUMENTATION LABORATORY COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HemosIL Plasmin Inhibitor
- Primary DI
- 08426950031734
- Version / Model
- 00020009200
- Catalog Number
- 00020009200
- 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
- 5
- Public Version Date
- 2021-07-13
- Public Version Status
- Update
- Public Device Record Key
- cd4e660e-29de-42c1-a7d0-c0a2b51fc32f
Device Description
HemosIL Plasmin Inhibitor
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | Hematology | 864.7290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56260 | Alpha-2-antiplasmin IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the quantitative detection of alpha-2-antiplasmin in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used in the diagnosis of congenital bleeding disorders or disseminated intravascular coagulation (DIC) and may be used to assess response to fibrinolytic therapy. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08426950031734 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K981696 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Unopened reagents are stable until the expiration date printed on the vial when stored at 2-8°C