| Primary Device ID | 30014613331063 | 
| NIH Device Record Key | 8dc614f1-12ce-420d-b825-9c8418ec3d8b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | DHI Media & Controls | 
| Version Model Number | 10-080100 | 
| Catalog Number | 10-080100 | 
| Company DUNS | 117359612 | 
| Company Name | DIAGNOSTIC HYBRIDS, INC. | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 | 
| technicalsupport@quidel.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 30014613331063 [Primary] | 
| KIP | FORMULATIONS, BALANCED SALT SOLUTIONS | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2018-10-29 | 
| Device Publish Date | 2018-09-26 | 
| 30014613331353 | REFEED MEDIUM ZERO-SERUM-3AB | 
| 30014613331346 | ZERO-SERUM REFEED MEDIUM-PSGA | 
| 30014613331339 | SUPER E-MIX REFEED MEDIUM | 
| 30014613331322 | SUPER E-MIX REFEED MEDIUM | 
| 30014613331315 | REFEED MEDIUM ZERO-SERUM-PS | 
| 30014613331308 | REFEED MEDIUM ZERO-SERUM-PS | 
| 30014613331292 | REFEED MEDIUM 10%FBS | 
| 30014613331285 | REFEED MEDIUM 10%FBS | 
| 30014613331278 | CTISOLATION MEDIUM | 
| 30014613331261 | REFEED MEDIUM RMIX 03T | 
| 30014613331254 | REFEED MEDIUM RMIX 03T | 
| 30014613331223 | REFEED MEDIUM 01 | 
| 30014613331216 | CMV TURBOTREAT MEDIUM | 
| 30014613331186 | MRC-5 GROWTH MEDIUM | 
| 30014613331179 | PLANTING MEDIUM BASE | 
| 30014613331162 | SUPPL FOR 10-200100 EU2 PLT MD | 
| 30014613331155 | STANDARD PLANTING MEDIUM | 
| 30014613331148 | REFEED MEDIUM 5% 500ML BTL | 
| 30014613331131 | DMEM, 10% FBS, 1000 ML | 
| 30014613331124 | HBSS, NO CA, NO MG | 
| 30014613331117 | HBSS, NO CA, NO MG | 
| 30014613331100 | TRYPSIN CONC, 7ML IN PBS | 
| 30014613331094 | TRYPSIN-EDTA | 
| 30014613331087 | PBS 10X | 
| 30014613331070 | HBSS DILUENT | 
| 30014613331063 | HBSS DILUENT | 
| 30014613331056 | ANTIBIOTIC SOLUTION | 
| 30014613331049 | GENTAMICIN 50 MG/ML | 
| 30014613331032 | AMPHOTERICIN B, 250 UG/ML | 
| 30014613331025 | PEN/STREP 10K/10K | 
| 30014613330998 | C. DIFFICILE ANTI-TOXIN REAGENT | 
| 30014613330981 | C. DIFFICILE TOXIN Control | 
| 30014613330974 | C. DIFFICILE SPEC. DILUENT | 
| 30014613330967 | C. DIFFICILE TOXIN DETECTION |