FDA UDI
In Commercial Distribution
🇺🇸 United States
directCHECK ACT+ Whole Blood Control Level 1
DI: 10711234170342
·
Model: 000DCGACT-1
·
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
Basic Information
- Brand Name
- directCHECK ACT+ Whole Blood Control Level 1
- Primary DI
- 10711234170342
- Version / Model
- 000DCGACT-1
- Catalog Number
- 000DCGACT-1
- Company Name
- ACCRIVA DIAGNOSTICS HOLDINGS, INC.
- Labeler DUNS
- 079299318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2022-01-21
- Public Version
- 2
- Public Version Date
- 2022-08-31
- Public Version Status
- Update
- Public Device Record Key
- 720314d9-1615-45c0-a634-dc62d9496d5c
Device Description
directCHECK GH100 ACT+L1 15/box
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
- Yes
- 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 |
|---|---|---|---|---|
| GGN | Plasma, Coagulation Control | Hematology | 864.5425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30590 | Multiple coagulation factor IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00711234170345 | GS1 | ||||
| Primary | 10711234170342 | GS1 |
Customer Contacts
- Phone
- 1-800-678-0710
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202101 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 35 – 46 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius