ichroma™ CRP i-CHOMRA CRP-25
GUDID 08806679001520
Boditech Med Inc.
C-reactive protein (CRP) IVD, kit, fluorescent immunoassay| Primary Device ID | 08806679001520 |
| NIH Device Record Key | b10eb49a-9629-4a61-a10f-b8a5b63114d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ichroma™ CRP |
| Version Model Number | i-CHOMRA CRP-25 |
| Catalog Number | i-CHOMRA CRP-25 |
| Company DUNS | 689062203 |
| Company Name | Boditech Med Inc. |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806679001520 [Primary] |
| GS1 | 18806679001527 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062981
FDA Product Code
| DCN | System, Test, C-Reactive Protein |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-06-17 |
| Device Publish Date | 2016-12-20 |
Devices Manufactured by Boditech Med Inc.
| 08806133032008 - ichroma Reader | 2025-03-03 |
| 08806133080849 - Swab-N-Go Home Test COVID-19 Ag | 2023-10-18 |
| 08806133010068 - AFIAS-50 | 2022-09-16 |
| 08806133010099 - ichroma Reader | 2022-06-10 |
| 08806133010136 - ALFIS-3 | 2021-12-14 FLUOROMETER FOR CLINICAL USE |
| 08806133005262 - AFIAS TSH-SP | 2020-06-17 AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test systerm for in vitro diagnostic |
| 08806133005279 - AFIAS TSH-VB | 2020-06-17 AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test systerm intended for in vitro d |
| 08806679001520 - ichroma™ CRP | 2020-06-17 |
| 08806679001520 - ichroma™ CRP | 2020-06-17 |
Trademark Results [ichroma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICHROMA 86472614 4976000 Live/Registered |
BODITECH MED INC. 2014-12-05 |
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