| Primary Device ID | 05060147022339 |
| NIH Device Record Key | 649f0530-db08-44a9-802d-b45591046075 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient |
| Version Model Number | 1 |
| Company DUNS | 626119668 |
| Company Name | SHIRE HUMAN GENETIC THERAPIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060147022339 [Primary] |
| PQD | Blood Specimen Collection Convenience Kit (Excludes Hiv) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-04-07 |
| Device Publish Date | 2019-08-28 |
| 00642621074000 - BAXJECT II Hi-Flow | 2023-10-12 Needleless Transfer Device |
| 05060147022339 - Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient | 2021-04-07The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting specimens from patients receiving ELAPRASE® or VPRIV® commercial therapy for the treatment of Hunter syndrome and Gaucher. |
| 05060147022339 - Anti-Drug Antibody Biomarker Specimen Collection Kit: Gaucher and Hunter Patient | 2021-04-07 The purpose of the Anti-Drug Antibody and Biomarker Specimen Collection Kit is to aid healthcare providers (HCPs) in collecting |