| Primary Device ID | 00843876000558 |
| NIH Device Record Key | 7376ced9-c0fb-41af-a44d-066b49e55ef8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CRYOcheck Factor VIII Chromogenic |
| Version Model Number | CCCF08 |
| Catalog Number | CCCF08 |
| Company DUNS | 244713368 |
| Company Name | Precision Biologic Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843876000558 [Primary] |
| GGP | Test, Qualitative And Quantitative Factor Deficiency |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-04 |
| Device Publish Date | 2020-07-27 |
| 00843876010557 - CRYOcheck Factor VIII Deficient Plasma with VWF | 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete |
| 00843876010564 - CRYOcheck Factor VIII Deficient Plasma with VWF | 2023-10-03 CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative dete |
| 00843876000596 - CRYOcheck Hex LA | 2023-05-10 CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulan |
| 00843876000558 - CRYOcheck Factor VIII Chromogenic | 2020-08-04CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use |
| 00843876000558 - CRYOcheck Factor VIII Chromogenic | 2020-08-04 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3. |
| 00843876000534 - CRYOcheck Lupus Negative Control | 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. |
| 00843876000541 - CRYOcheck Lupus Negative Control | 2020-03-16 Prepared from human source plasma and recommended as a negative control in assays for lupus anticoagulant. |
| 00843876000503 - CRYOcheck™ FVIII Inhibitor Kit | 2019-04-02 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable perf |
| 00843876000015 - CRYOcheck™ Pooled Normal Plasma | 2018-07-06 |