N/A

GUDID 00850041798035

For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity within a short period.

Key Scientific Products Incorporated

Pyrrolidonyl arylamidase (PYR) activity IVD, kit, rapid colorimetric, clinical

• Primary Device ID: 00850041798035
• NIH Device Record Key: fb1e6257-d9c8-4aaf-b619-3e4834770df7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: K1538B
• Company DUNS: 783601115
• Company Name: Key Scientific Products Incorporated
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store between 2 and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041798035 [Primary]

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: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [N/A]

• 00850041798004: For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit
• 00850041798035: For qualitative and/or Semi-Qualitative detection of pyrrolidonyl arylamidase (PYR) activity wit
• 00850041798028: PEP REAGENT
• 00850041798011: he IDENTICULT-AE test is intended for use in the rapid identification of group A streptococci an
• 00850041798042: Pep ReagentT
• 00850041798059: White beads