FDA UDI
In Commercial Distribution
🇺🇸 United States
APTT-SA (Soluble Activator) Reagent Kit
DI: M52553880
·
Model: 5388
·
HELENA LABORATORIES CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- APTT-SA (Soluble Activator) Reagent Kit
- Primary DI
- M52553880
- Version / Model
- 5388
- Company Name
- HELENA LABORATORIES CORPORATION
- Labeler DUNS
- 079396131
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-07
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0aadf151-9619-46a7-9545-94d91adbedb7
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 |
|---|---|---|---|---|
| GFO | ACTIVATED PARTIAL THROMBOPLASTIN | Hematology | 864.7925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55982 | Activated partial thromboplastin time (APTT) 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 quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M52553880 | HIBCC |
Customer Contacts
- Phone
- +1(800)231-5663 ext. 1600
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K915418 | 000 |