| Primary Device ID | 00892093002098 |
| NIH Device Record Key | 26ad6576-09fb-4153-a264-1696e240b7db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wells for Pyramid Dipwell Tray |
| Version Model Number | DTW-40 |
| Company DUNS | 054220009 |
| Company Name | Lincoln Diagnostics, Inc. |
| Device Count | 40 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00892093002098 [Primary] |
| GS1 | 00892093002197 [Unit of Use] |
| SCL | Allergen And Vaccine Delivery Needles |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
| 00892093002005 - Multi-Test Skin Test System | 2025-12-22 Multiple head skin test applicator for allergy testing, box of 6. |
| 00892093002012 - Multi-Test Skin Test System | 2025-12-22 Multiple head skin test applicator for allergy testing with eight testing heads, case of 600. |
| 00892093002142 - Multi-Test II Skin Test System | 2025-12-22 Multiple skin test applicator for allergy testing, case of 600. |
| 00892093002043 - Duotip-Test Skin Test System | 2025-12-22 Single skin test applicator for allergy testing, box of 400. |
| 00892093002050 - Duotip-Test II Skin Test System | 2025-12-22 Single device skin test applicator for allergy testing, box of 400. |
| 00892093002067 - Multi-Test Dipwell Tray | 2025-12-22 Antigen tray for use as part of the Multi-Test II and Multi-Test PC system, accessory. |
| 00892093002074 - Multi-Test Dipwell Tray, non-capped | 2025-12-22 Antigen tray for use with Multi-Test system, accessory. |
| 00892093002081 - Duotip-Test Dipwell Tray | 2025-12-22 Antigen tray for use with Duotip-Test Skin Test System, accessory. |