Carrier Box, ETC, Slide, IVD 800-20301

GUDID 10888234102670

BIOARRAY SOLUTIONS LTD

Optical instrument calibration/verification reference standard IVD
Primary Device ID10888234102670
NIH Device Record Keyd8fde59d-e0e1-4293-b117-ac4aea47d355
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarrier Box, ETC, Slide, IVD
Version Model Number800-20301
Catalog Number800-20301
Company DUNS949103725
Company NameBIOARRAY SOLUTIONS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110888234102670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NSUInstrumentation For Clinical Multiplex Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-24

Devices Manufactured by BIOARRAY SOLUTIONS LTD

10888234100065 - Immucor Precise TypeTM Human Erythrocyte Antigen M2018-07-06
10888234100621 - Filled Vial, Clean-up, 330uL2018-07-06
10888234100645 - Filled Vial, eMAPTM Elongation Mix2018-07-06
10888234100669 - Filled Vial, HEA 1.2 PCR Mix2018-07-06
10888234100683 - Filled Vial, Lambda Exonuclease2018-07-06
10888234100836 - Filled Vial,Negative Control 1mL2018-07-06
10888234100928 - Filled Vial,HotStarTaq DNA Polymerase2018-07-06
10888234102205 - BioArray Assay Imaging SystemTM (AIS) 400C2018-07-06

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