Mast Assure M10113

GUDID 15060392376468

M10113 - Shigella boydii Polyvalent Typing Antiserum - POLY C1 Types 8, 9, 10, 11 - 2ml

MAST GROUP LIMITED

Shigella boydii culture isolate antigen IVD, kit, agglutination

• Primary Device ID: 15060392376468
• NIH Device Record Key: 15233bbd-f305-44a6-a6cf-2916d972f80a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mast Assure
• Version Model Number: M10113
• Catalog Number: M10113
• Company DUNS: 212623821
• Company Name: MAST GROUP LIMITED
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060392376468 [Primary]

FDA Product Code

• GNB: Antisera, All Types, Shigella Spp.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-10-10

On-Brand Devices [Mast Assure]

• 15060392378042: M10106 - Shigella Antisera Set 3 - contains 8 polyvalent antisera for serotyping Shigella dysent
• 15060392377816: Shigella flexneri Type IV Antiserum
• 15060392377625: Salmonella Antisera Set 1
• 15060392376536: Vibrio cholerae Monovalent Antiserum - O139 (Bengal) - 2ml
• 15060392376529: Vibrio cholerae Monovalent Antiserum - OGAWA - 2ml
• 15060392376505: Vibrio cholerae Polyvalent Antiserum - POLY (INABA, OGAWA) - 2ml
• 15060392376499: Shigella sonnei Polyvalent Antiserum - POLY D Phase I & II - 2ml
• 15060392376482: M10154 - Shigella boydii Polyvalent Typing Antiserum - POLY C3 Types 16, 17, 18 - 2ml
• 15060392376475: M10114 - Shigella boydii Polyvalent Typing Antiserum - POLY C2 Types 12, 13, 14, 15 - 2ml
• 15060392376468: M10113 - Shigella boydii Polyvalent Typing Antiserum - POLY C1 Types 8, 9, 10, 11 - 2ml
• 15060392376451: Shigella boydii Polyvalent Typing Antiserum - POLY C Types 1, 2, 3, 4, 5, 6, 7 - 2ml
• 15060392376444: Shigella flexneri Polyvalent Typing Antiserum - POLY B Types I, II, III, IV, V, VI, Groups (3)
• 15060392376437: M10110 - Shigella dysenteriae Polyvalent Typing Antiserum - POLY A1 Types 8, 9, 10, 11, 12 - 2
• 15060392376420: Shigella dysenteriae Polyvalent Typing Antiserum - POLY A Types 1, 2, 3, 4, 5, 6, 7 - 2ml
• 15060392376383: Shigella flexneri Monovalent Typing Antiserum - Type VI - 2ml
• 15060392376369: Shigella flexneri Monovalent Typing Antiserum - Type II - 2ml
• 15060392376352: Shigella flexneri Monovalent Typing Antiserum - Type I - 2ml
• 15060392376291: Escherichia coli Monovalent O Antiserum - Factor O157 - 2ml
• 15060392376185: Salmonella O Antiserum Polyvalent - Kauffmann White Schem Groups A to S - 2ml
• 15060392376154: POLY O Factor O2, O4, O7, O8, O9, O9, 46, O3, 10 and O1,3,19
• 15060392375997: Salmonella Monovalent H Antiserum - Factor H-v - 2ml
• 15060392375904: M10364 - Salmonella Monovalent H Antiserum - Factor H-f - 2ml
• 15060392375874: Salmonella Monovalent H Antiserum - Factor H-2 - 2ml
• 15060392375850: Salmonella Monovalent H Antiserum - Factor H-k - 2ml
• 15060392375843: Salmonella Monovalent H Antiserum - Factor H-i
• 15060392375690: Salmonella Monovalent Antiserum - Factor Vi - 2ml
• 15060392375652: Salmonella Monovalent O Antiserum - Factor O9 - 2ml
• 15060392375645: Salmonella Monovalent O Antiserum - Factor O8 - 2ml
• 15060392375638: Salmonella Monovalent O Antiserum - Factor O7 - 2ml
• 15060392375621: Salmonella Monovalent O Antiserum - Factor O4 - 2ml
• 15060392375614: Salmonella Monovalent O Antiserum - Factor O2 - 2ml