| Primary Device ID | 00850041798042 |
| NIH Device Record Key | 31a9d8a1-95ce-44bf-afa4-a8c65ce6313d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | K982375 |
| Company DUNS | 783601115 |
| Company Name | Key Scientific Products Incorporated |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850041798042 [Primary] |
| GS1 | 10850041798049 [Package] Package: Box [1 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2023-10-25 |
| 00850041798004 | For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit |
| 00850041798035 | For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit |
| 00850041798028 | PEP REAGENT |
| 00850041798011 | he IDENTICULT-AE test is intended for use in the rapid identification of group A streptococci an |
| 00850041798042 | Pep ReagentT |
| 00850041798059 | White beads |