FDA UDI
In Commercial Distribution
🇺🇸 United States
Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays
DI: M52514790
·
Model: 1479
·
HELENA LABORATORIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Scale Set Solutions for AggRAM & PACKS-4 Platelet Assays
- Primary DI
- M52514790
- Version / Model
- 1479
- Company Name
- HELENA LABORATORIES CORPORATION
- Labeler DUNS
- 079396131
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-17
- Public Version
- 7
- Public Version Date
- 2022-12-20
- Public Version Status
- Update
- Public Device Record Key
- dd2b01b0-68a5-41ad-aeba-2888926590a6
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
- 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 |
|---|---|---|---|---|
| JJY | Multi-analyte controls, all kinds (assayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58048 | Optical laboratory instrument performance standard calibrator/control IVD, single-use | A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M52514790 | HIBCC |
Customer Contacts
- Phone
- +1(800)231-5663 ext. 1600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K924915 | 000 |