| Primary Device ID | 05999860094173 |
| NIH Device Record Key | 06706bdd-2753-4525-993a-16549d39f8da |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 5x TBS Wash Buffer |
| Version Model Number | TWB56 |
| Company DUNS | 427395277 |
| Company Name | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag |
| 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 | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com | |
| Phone | +3612794400 |
| sales@diatron.com |
| Handling Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05999860094173 [Package] Contains: 15999860094170 Package: [4 Units] In Commercial Distribution |
| GS1 | 15999860094170 [Primary] |
| JCB | Detergent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-19 |
| Device Publish Date | 2025-12-11 |
| 05999860094173 - 5x TBS Wash Buffer | 2025-12-19 The product is intended as a wash buffer for the chemiluminescence reaction in the fully automated chemiluminescence immunoassay analyzer KleeYa®. |
| 05999860094173 - 5x TBS Wash Buffer | 2025-12-19 The product is intended as a wash buffer for the chemiluminescence reaction in the fully automated chemiluminescence immunoassa |
| 05999883586419 - P780 Clinical Chemistry Analyzer with ISE module | 2025-07-18 The Pictus 780 is an in vitro diagnostic analyzer made for the continuous and automatic execution of clinical chemistry tests, a |
| 05999883586426 - P780 Clinical Chemistry Analyzer | 2025-07-18 The Pictus 780 is an in vitro diagnostic analyzer made for the continuous and automatic execution of clinical chemistry tests, a |
| 05999883586907 - Atellica DT Cuvettes (280pcs) | 2025-06-23 The cuvette strips are manufactured especially for Atellica® DT 250 Analyzer and are intended to use for performing tests only |
| 15999883586744 - Atellica DT 250 Analyzer | 2025-05-08 The Atellica® DT 250 analyzer is a fully automated wet-chemistry analyzer for in vitro diagnostic use. The analyzer is used to |
| 25999883586758 - Atellica DT Solution 1 (S1) | 2025-05-08 Atellica DT Solution 1 (S1) contains stabilized and micro- filtered hypochlorite and detergents, for regular cleaning and rinsin |
| 15999883586850 - Atellica DT Solution 3 (S3) | 2025-05-08 Atellica DT Solution 3 (S3) contains concentrated detergents, for regular cleaning and rinsing of Atellica DT 250 Analyzer’s p |
| 25999883586864 - Atellica DT Solution 4 (S4) | 2025-05-08 Atellica DT Solution 4 (S4) is used for the automatic decontamination and cleaning of cuvettes after each use and for the remova |