FDA UDI
In Commercial Distribution
🇺🇸 United States
AggreDYNE AA Assay
DI: 00856893004010
·
Model: A-100
·
AGGREDYNE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- AggreDYNE AA Assay
- Primary DI
- 00856893004010
- Version / Model
- A-100
- Company Name
- AGGREDYNE, INC.
- Labeler DUNS
- 078703793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-01
- Public Version
- 1
- Public Version Date
- 2019-02-01
- Public Version Status
- New
- Public Device Record Key
- ada84b0d-15e2-4956-9608-c381fe0e0224
Device Description
AA Assay Cartridge, Single Use Packaged
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | Hematology | 864.5700 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56092 | Platelet aggregation study IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20856893004014 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00856893004010 | GS1 | ||||
| Package | 10856893004017 | GS1 | Case | 20 | In Commercial Distribution |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius