| Primary Device ID | 00850051429660 |
| NIH Device Record Key | b6fe35f9-3cb8-41ca-8785-60a09a5209c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fort Worth Diagnostics |
| Version Model Number | MEASPOS |
| Catalog Number | MEASPOS |
| 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 | 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850051429660 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-30 |
| Device Publish Date | 2025-06-20 |
| 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 |