Fort Worth Diagnostics GBS001

GUDID 00850051429073

Group B Streptococcus Primer Set

Fort Worth Diagnostics, LLC

Assay development analyte-specific reagent IVD

• Primary Device ID: 00850051429073
• NIH Device Record Key: 17abf642-3393-467a-8d61-7b9c77f813df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fort Worth Diagnostics
• Version Model Number: GBS001
• Catalog Number: GBS001
• Company DUNS: 118977483
• Company Name: Fort Worth Diagnostics, LLC
• 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: false
• Lot Batch: false
• Serial Number: false
• 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

Customer Support Contacts

• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com
• Phone: 8174358511
• Email: customerservice@fwdx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -20 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850051429073 [Primary]

FDA Product Code

• MVU: Reagents, Specific, Analyte

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: 2024-03-11
• Device Publish Date: 2024-03-01

On-Brand Devices [Fort Worth Diagnostics]

• 00850051429028: Anaplasma Primer Set
• 00850051429004: Babesia Primer Set
• 00850051429035: Borrelia Primer Set
• 00850051429325: Ureaplasma Primer Set
• 00850051429318: Mycoplasma Primer Set
• 00850051429301: Megasphaera Primer Set
• 00850051429295: Gardnerella vaginalis Primer Set
• 00850051429288: Candida spp Primer Set
• 00850051429271: Candida krusei Primer Set
• 00850051429264: Candida glabrata Primer Set
• 00850051429257: BVAB2 Primer Set
• 00850051429240: Atopobium vaginae Primer Set
• 00850051429233: Borrelia Primer Set
• 00850051429226: JCV Primer Set
• 00850051429219: RSV Primer Set
• 00850051429202: Influenza B Primer Set
• 00850051429196: Influenza A Primer Set
• 00850051429189: Influenza A Primer Set
• 00850051429172: SARS-CoV-2 Primer Set
• 00850051429165: Asuragen Internal Process Control Primer Set
• 00850051429158: Ehrlichia Primer Set
• 00850051429141: Borrelia miyamotoi Primer Set
• 00850051429134: Babesia Primer Set
• 00850051429127: Anaplasma Primer Set
• 00850051429110: HSV-2 Primer Set
• 00850051429103: HSV-1 Primer Set
• 00850051429080: Bacillus atrophaeus Primer Set
• 00850051429073: Group B Streptococcus Primer Set
• 00850051429066: Candida auris Primer Set
• 00850051429059: Candida auris Primer Set
• 00850051429042: Ehrlichia Primer Set
• 00850051429332: Adenovirus Primer Set
• 00850051429349: Babesia microti Primer Set
• 00850051429363: Borrelia miyamotoi Primer Set
• 00850051429417: HPV Genotype 52 Primer Set
• 00850051429400: HPV Genotype 45 Primer Set
• 00850051429394: HPV Genotype 33 Primer Set
• 00850051429387: HPV Genotype 31 Primer Set
• 00850051429370: Babesia Primer Set
• 00850051429431: HHV-6B Primer Set
• 00850051429424: HHV-6A Primer Set
• 00850051429479: Enterovirus Primer Set
• 00850051429462: Parechovirus Primer Set
• 00850051429455: Influenza A H5N1 Primer Set
• 00850051429486: Anaplasma Primer Set
• 00850051429493: Anaplasma Primer Set
• 00850051429509: Influenza A H5N1 Primer Set
• 00850051429523: Adenovirus Primer Set
• 00850051429554: VZV Primer Set
• 00850051429547: Measles Primer Set