Baebies 6-HMU GALC 2103

GUDID 00819704020265

6-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.

BAEBIES, INC.

Newborn metabolic screen/congenital disorder IVD, reagent
Primary Device ID00819704020265
NIH Device Record Key61964cb8-07eb-47c2-8b60-a90fd2502630
Commercial Distribution StatusIn Commercial Distribution
Brand NameBaebies 6-HMU GALC
Version Model Number2103
Catalog Number2103
Company DUNS079264306
Company NameBAEBIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-244-4034
Emailtechsupport@baebies.com
Phone844-244-4034
Emailtechsupport@baebies.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius
Storage Environment TemperatureBetween -80 Degrees Celsius and -70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819704020265 [Primary]
GS110819704020262 [Package]
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

MVUReagents, Specific, Analyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-12

Devices Manufactured by BAEBIES, INC.

00819704020265 - Baebies 6-HMU GALC2019-01-146-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.
00819704020265 - Baebies 6-HMU GALC2019-01-14 6-HMU GALC Substrate. Analyte Specific Reagent - Analytical and performance characteristics are not established.
10819704020279 - Baebies Stop Solution2019-01-14 Baebies Stop Solution General Purpose Reagent, For Laboratory Use.
00819704020289 - Baebies 6-HMU Dilution Set2019-01-14 6-HMU Dilution Set General Purpose Reagent, For Laboratory Use.
10819704020293 - Baebies Extraction Solution2019-01-14 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 IDS2018-11-05 4-MU IDS Reagent Tube, 4.3mL Analyte Specific Reagent - Analytical and performance characteristics are not established.
10819704020316 - Baebies 4-MU Dilution Set2018-11-05 4-MU Dilution Set General Purpose Reagent, For Laboratory Use.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.