Fungal Serology 200160

GUDID 10634853000176

Clarifying Reagent (Sodium Citrate), 20mL

MICROBIOLOGICS INC.

Enzyme immunoassay (EIA) generic reagent kit IVD

• Primary Device ID: 10634853000176
• NIH Device Record Key: a053f085-4e3e-4f76-a1f8-1b2c29e53864
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fungal Serology
• Version Model Number: 200160
• Catalog Number: 200160
• Company DUNS: 060467826
• Company Name: MICROBIOLOGICS 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com
• Phone: +1(320)253-7400
• Email: techsupport@microbiologics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10634853000176 [Primary]

FDA Product Code

• JTO: Discs, strips and reagents, microorganism differentiation

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: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [Fungal Serology]

• 10634853000121: Histoplasma capsulatum Antiserum, 1mL ID/EXO
• 10634853000114: Histoplasma capsulatum Antiserum (H&M), 2mL
• 10634853000107: Histoplasma capsulatum Antigen (H&M), 2mL ID/EXO
• 10634853000091: Histoplasma capsulatum Antigen (H&M), 1mL
• 10634853000084: Coccidioides immitis Antiserum (HS), ID/EXO
• 10634853000077: Coccidioides immitis Antiserum (F), 2mL
• 10634853000060: Coccidioides immitis Antigens (HS), 2mL ID/EXO
• 10634853000053: Coccidioides immitis Antigen (F), 1mL
• 10634853000046: Blastomyces dermatitidis Antiserum, 2mL
• 10634853000039: Blastomyces dermatitidis Antiserum, 1mL ID/EXO
• 10634853000022: Blastomyces dermatitidis Antigen (A), 2mL ID/EXO
• 10634853000015: Blastomyces dermatitidis Antigen (A), 1mL
• 10634853000435: Aspergillus Pooled Antiserum, 2mL
• 10634853000428: Aspergillus Pooled Antigen, 1mL
• 10634853000411: Aspergillus nidulans Antiserum, 2mL
• 10634853000404: Aspergillus nidulans Antigen, 1mL
• 10634853000398: Aspergillus terreus Antiserum, 2mL
• 10634853000343: Asp. Immunodiffusion Agar, 12mL Deeps
• 10634853000312: Asp. Immunodiffusion Agar Plates, 8 - 7 Well Pattern
• 10634853000305: Asp. Immunodiffusion Agar Plates, 3 - 7 Well Pattern
• 10634853000299: Asp. Immunodiffusion Agar Plates, 1 - 7 Well Pattern
• 10634853000275: Aspergillus niger Antiserum, 2mL
• 10634853000268: Aspergillus fumigatus Antiserum, 2mL
• 10634853000251: Aspergillus flavus Antiserum, 2mL
• 10634853000244: Aspergillus niger Antigen, 1mL
• 10634853000237: Aspergillus fumigatus Antigen, 1mL
• 10634853000220: Aspergillus flavus Antigen, 1mL
• 10634853000213: Candida Antiserum, 2mL
• 10634853000206: Candida Antigen, 1mL
• 10634853000183: Immunodiffusion Agar, 12mL Deeps
• 10634853000176: Clarifying Reagent (Sodium Citrate), 20mL
• 10634853000169: Normal Rabbit Serum (Negative), 1mL
• 10634853000152: Immunodiffusion Agar Plates, 8 - 7 Well Pattern
• 10634853000145: Immunodiffusion Agar Plates, 3 - 7 Well Pattern
• 10634853000138: Immunodiffusion Agar Plates, 1 - 7 Well Pattern