| Primary Device ID | 10816101020772 |
| NIH Device Record Key | eb1e06ab-ccab-4768-a8d9-8360e2e140fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | R. rickettsii Substrate Slide |
| Version Model Number | IF0102 |
| Catalog Number | IF0102 |
| Company DUNS | 080271715 |
| Company Name | DIASORIN MOLECULAR LLC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 1-562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 1-562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 1-562-240-6500 |
| TS.Molecular@DiaSorin.com | |
| Phone | 1-562-240-6500 |
| TS.Molecular@DiaSorin.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816101020772 [Primary] |
| MVU | Reagents, Specific, Analyte |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-24 |
| Device Publish Date | 2025-12-16 |
| 10816101020772 - R. rickettsii Substrate Slide | 2025-12-24 |
| 10816101020772 - R. rickettsii Substrate Slide | 2025-12-24 |
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| 10816101027306 - Borrelia miyamotoi Primer Pair | 2024-12-31 |
| 10816101027207 - Factor V HyBeacon II Primer Pair | 2024-10-02 |
| 10816101027221 - Prothrombin (FII) HyBeacon Gen II Primer Pair | 2024-10-02 |
| 10816101027283 - Monkeypox Primer Pair | 2024-08-30 |