FDA UDI
In Commercial Distribution
🇺🇸 United States
CRYOcheck Hex LA
DI: 00843876000596
·
Model: HEXLA-M
·
Precision Biologic Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CRYOcheck Hex LA
- Primary DI
- 00843876000596
- Version / Model
- HEXLA-M
- Catalog Number
- HEXLA-M
- Company Name
- Precision Biologic Inc
- Labeler DUNS
- 244713368
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-02
- Public Version
- 1
- Public Version Date
- 2023-05-10
- Public Version Status
- New
- Public Device Record Key
- d5ee151b-9c8a-48d8-9c15-1ac5333b8556
Device Description
CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
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 |
|---|---|---|---|---|
| GFO | Activated Partial Thromboplastin | Hematology | 864.7925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56202 | Lupus anticoagulant marker IVD, kit, clotting | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen, using a clotting method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843876000596 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193556 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – -70 Degrees Celsius