Fort Worth Diagnostics BMI002

GUDID 00850051429349

Babesia microti Primer Set

Fort Worth Diagnostics, LLC

Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD Assay development analyte-specific reagent IVD

Primary Device ID	00850051429349
NIH Device Record Key	4ceae547-5e03-4de8-9bbd-92fcbe99d2d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fort Worth Diagnostics
Version Model Number	BMI002
Catalog Number	BMI002
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	00850051429349 [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	2024-05-07
Device Publish Date	2024-04-29

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