StrepPRO™ PL039HD

GUDID 00819398027939

StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 tests Extraction 1 Reagent for the rapid latex agglutination test for the identification of streptococcal groups.

HARDY DIAGNOSTICS

Beta-haemolytic Streptococcus serological grouping IVD, reagent

• Primary Device ID: 00819398027939
• NIH Device Record Key: 98744bb3-3584-4ae7-9e17-1f91da9e476b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StrepPRO™
• Version Model Number: PL039HD
• Catalog Number: PL039HD
• Company DUNS: 039981550
• Company Name: HARDY DIAGNOSTICS
• 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: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com
• Phone: 800-266-2222
• Email: techservice@hardydiagnostics.com

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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• 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	00819398027939 [Primary]

FDA Product Code

• GTZ: Antisera, All Groups, Streptococcus 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: 2020-09-10
• Device Publish Date: 2020-09-02

On-Brand Devices [StrepPRO™]

• 00819398027984: StrepPRO™ Streptococcal Grouping Kit, rapid latex agglutination test for Streptococcus Lancefi
• 00819398027946: StrepPRO™ Positive Control, for the rapid latex agglutination test, 60 tests Positive Control
• 00819398027939: StrepPRO™ Extraction Reagent 3, for the rapid latex agglutination test, 60 tests Extraction 1
• 00819398027922: StrepPRO™ Extraction Reagent 2, for the rapid latex agglutination test, 60 tests, Extraction 2
• 00819398027915: StrepPRO™ Extraction Reagent 1, for the rapid latex agglutination test, 60 tests Extraction 1
• 00819398027908: StrepPRO™ Grouping Reagent G, for the rapid latex agglutination test, 60 tests Grouping reagen
• 00819398027892: StrepPRO™ Grouping Reagent F, for the rapid latex agglutination test, 60 test Grouping reagent
• 00819398027885: StrepPRO™ Grouping Reagent D, for the rapid latex agglutination test, 60 tests Grouping reagen
• 00819398027878: StrepPRO™ Grouping Reagent C, for the rapid latex agglutination test, 60 tests Grouping reagen
• 00819398027861: Grouping Reagent B, for the rapid latex agglutination test, 60 tests Grouping reagent for the ra
• 00819398027854: Grouping Reagent A, for the rapid latex agglutination test, 60 tests Grouping reagent for the ra