Dermatophyte and C. albicans Real Time PCR kit 99462

GUDID 05713106994627

Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.

Ssi Diagnostica A/S

Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT) Multiple dermatophyte species nucleic acid IVD, kit, nucleic acid technique (NAT)

• Primary Device ID: 05713106994627
• NIH Device Record Key: e36ef7e7-bad7-4b7c-9c7e-f66430c346e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermatophyte and C. albicans Real Time PCR kit
• Version Model Number: 99462
• Catalog Number: 99462
• Company DUNS: 305684449
• Company Name: Ssi Diagnostica A/S
• 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: true

Customer Support Contacts

• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com
• Phone: +4548299100
• Email: info@ssidiagnostica.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stored at a dark place at -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713106994627 [Primary]

FDA Product Code

• JSR: Kit, Identification, Dermatophyte

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: 2022-12-05
• Device Publish Date: 2022-11-25

Devices Manufactured by Ssi Diagnostica A/S

• 05713106994627 - Dermatophyte and C. albicans Real Time PCR kit: 2022-12-05Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of general dermatophytes (pan-dermatophytes), Trichophyton (T.) rubrum and Candida (C.) albicans in nail, skin, and hair specimens.
• 05713106994627 - Dermatophyte and C. albicans Real Time PCR kit: 2022-12-05 Intended use The Dermatophyte and C. albicans Real Time PCR Kit is an in vitro diagnostic kit for the quantitative detection of
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• 05713106544044 - E. coli H6 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544068 - E. coli H7 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544075 - E. coli H8 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use
• 05713106544099 - E. coli H9 serum, 5 mL: 2021-08-19 Rabbit antiserum, Ready to use