Fungal Serology 200260

GUDID 10634853000121

Histoplasma capsulatum Antiserum, 1mL ID/EXO

MICROBIOLOGICS INC.

Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control Histoplasma capsulatum exoantigen IVD, control

• Primary Device ID: 10634853000121
• NIH Device Record Key: 05204cdd-9b43-4dc1-bc23-62b215429043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fungal Serology
• Version Model Number: 200260
• Catalog Number: 200260
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Can be kept at -20 deg C. However, do not freeze and thaw repeatedly.
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10634853000121 [Primary]

FDA Product Code

• GMK: Antiserum, Positive Control, Histoplasma Capsulatum

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-20
• Device Publish Date: 2016-09-15

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