Primary Device ID | 00850051429431 |
NIH Device Record Key | 98f24011-69c6-4086-9d12-0f28e08cc80a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fort Worth Diagnostics |
Version Model Number | HHV6B002 |
Catalog Number | HHV6B002 |
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 |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com | |
Phone | 8174358511 |
customerservice@fwdx.com |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00850051429431 [Primary] |
MVU | Reagents, Specific, Analyte |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-07-23 |
Device Publish Date | 2024-07-15 |
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 |