Primary Device ID | 10819704020316 |
NIH Device Record Key | 51e49b93-939f-40e3-811c-10b4d0d34fa7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Baebies 4-MU Dilution Set |
Version Model Number | 3952 |
Catalog Number | 3952 |
Company DUNS | 079264306 |
Company Name | BAEBIES, INC. |
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 | 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 |
Phone | 844-244-4034 |
techsupport@baebies.com | |
Phone | 844-244-4034 |
techsupport@baebies.com |
Storage Environment Temperature | Between -80 Degrees Celsius and -70 Degrees Celsius |
Storage Environment Temperature | Between -80 Degrees Celsius and -70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00819704020319 [Primary] |
GS1 | 10819704020316 [Package] Contains: 00819704020319 Package: Box [12 Units] In Commercial Distribution |
PPM | General Purpose Reagent |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-11-05 |
Device Publish Date | 2018-10-04 |
00819704020265 - Baebies 6-HMU GALC | 2019-01-14 6-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established. |
10819704020279 - Baebies Stop Solution | 2019-01-14 Baebies Stop Solution General Purpose Reagent, For Laboratory Use. |
00819704020289 - Baebies 6-HMU Dilution Set | 2019-01-14 6-HMU Dilution Set General Purpose Reagent, For Laboratory Use. |
10819704020293 - Baebies Extraction Solution | 2019-01-14 Baebies Extraction Solution General Purpose Reagent, For Laboratory Use |
00819704020197 - SEEKER™ | 2019-01-04 The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes. |
00819704020203 - SEEKER™ | 2019-01-04 SEEKER™ Instrument & Accessories The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determinati |
10819704020309 - Baebies 4-MU IDS | 2018-11-05 4-MU IDS Reagent Tube, 4.3mL Analyte Specific Reagent - Analytical and performance characteristics are not established. |
10819704020316 - Baebies 4-MU Dilution Set | 2018-11-054-MU Dilution Set General Purpose Reagent, For Laboratory Use. |
10819704020316 - Baebies 4-MU Dilution Set | 2018-11-05 4-MU Dilution Set General Purpose Reagent, For Laboratory Use. |