Shigella Antisera Set 2 M10105

GUDID 15060392378035

Shigella Antisera Set 2 - A set containing 8 polyvalent and 11 monovalent antisera for serotyping Shigella, dysenteriae, Shigella flexneri, Shigella b

MAST GROUP LIMITED

Multiple Shigella species culture isolate antigen IVD, kit, agglutination
Primary Device ID15060392378035
NIH Device Record Key16e68aea-9f07-475c-a276-01e56de79c14
Commercial Distribution StatusIn Commercial Distribution
Brand NameShigella Antisera Set 2
Version Model NumberM10105
Catalog NumberM10105
Company DUNS212623821
Company NameMAST GROUP LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS115060392378035 [Primary]

FDA Product Code

GNBAntisera, All Types, Shigella Spp.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-17

Devices Manufactured by MAST GROUP LIMITED

15060392377601 - Mast Assure Antisera2022-04-14 M11306 - Haemophilus influenzae Capsular Typing Antiserum - Type e - 1 pack of 2ml
15060392375768 - Mast Assure Antisera2022-04-13 M10325 - Salmonella Monovalent O Antiserum - Factor O35 - 1 pack of 2ml
15060392376390 - Mast Assure Antisera2021-10-25 M10136 - Shigella boydii Monovalent Typing Antiserum - Type 2 - 1 pack of 2ml
15060392377861 - Mast Assure Antisera2021-10-25 M10137 - Shigella boydii Type 3 Antiserum - 1 pack of 2ml
15060392376178 - Mast Assure Antisera2021-09-30 M14294 - Salmonella O Antiserum Polyvalent - Kauffmann White Schem Groups A to G - 1 pack of 2ml
15060392376338 - Mast Assure Antisera2021-09-30 M11303 - Haemophilus influenzae Capsular Typing Antiserum - Type b - 1 pack of 2ml
15060392375966 - Mast Assure Antisera2021-08-13 M10335 - Salmonella Monovalent H Antiserum - Factor H-L - 2ml
15060392377717 - Mast Assure Antisera2021-08-13 M10120 - Shigella dysenteriae Type 5 Antiserum - 1 pack of 2ml

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