| Primary Device ID | 06973685471325 |
| NIH Device Record Key | c18a3a91-6664-4b0d-b07e-576cf9f0d468 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReadiMag FFPE DNA/RNA Kit |
| Version Model Number | 64Test/Kit |
| Catalog Number | 3000000000435 |
| Company DUNS | 561011079 |
| Company Name | 3D Biomedicine Science & Technology Co., Limited |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 06973685471325 [Primary] |
| JJH | Clinical Sample Concentrator |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-03 |
| Device Publish Date | 2023-09-25 |
| 06973685471387 - ReadiMag™ gDNA Isolation Kit | 2024-01-23 The ReadiMag™ gDNA Isolation Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from b |
| 06973685471325 - ReadiMag FFPE DNA/RNA Kit | 2023-10-03The ReadiMag FFPE DNA/RNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA/RNA from formalin-fixed, paraffin-embedded (FFPE) biological specimens. |
| 06973685471325 - ReadiMag FFPE DNA/RNA Kit | 2023-10-03 The ReadiMag FFPE DNA/RNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA/RNA from fo |
| 06973685471332 - ReadiMag™ FFPE DNA Isolation Kit | 2023-09-05 The ReadiMag™ FFPE DNA Isolation Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA fr |
| 06973685471394 - 96A Automated Viral DNA/RNA Isolation Kit | 2022-10-10 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specim |
| 06973685478027 - Automated Nucleic Acids Extraction System ANDiS 396 | 2022-09-28 The device is used for extraction and purification of nucleic acid in clinical samples. |
| 06973685471912 - ReadiMag Pathogen Nucleic Acid Isolation Kit | 2022-08-01 The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification |
| 06973685471356 - 96A Automated Viral DNA/RNA Isolation Kit | 2022-06-21 96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specim |
| 06973685471189 - ReadiMag FFPE DNA Kit | 2022-06-03 The ReadiMag FFPE DNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from formalin-f |