Tanner Scientific® TNR IFOB36
GUDID 00850011007167
Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX
MERCEDES MEDICAL, LLC
Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, immunochromatographic test (ICT), rapid Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical Faecal occult blood IVD, kit, rapid ICT, clinical| Primary Device ID | 00850011007167 |
| NIH Device Record Key | 09b66a5e-511b-4098-a0ff-9251f4f23ee4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tanner Scientific® |
| Version Model Number | TNR IFOB36 |
| Catalog Number | TNR IFOB36 |
| Company DUNS | 834472680 |
| Company Name | MERCEDES MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850011007167 [Primary] |
| GS1 | 10850011007164 [Package] Package: Inner Pack [36 Units] In Commercial Distribution |
| GS1 | 20850011007161 [Package] Contains: 10850011007164 Package: Case [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110309
FDA Product Code
| KHE | Reagent, Occult Blood |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-15 |
On-Brand Devices [Tanner Scientific®]
| 00850011007174 | Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/S |
| 00850011007167 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 36/BX |
| 00850011007150 | Tanner Scientific CLIA waived IFOB; Fecal Immunochemcial Test Kit 20/BX |
| 00850011007143 | Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gr |
| 20850011007130 | Tanner Scientific CLIA waived 13 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/TCA/THC |
| 20850011007123 | Tanner Scientific CLIA waived Drug Cup; 12Panel AMP/BAR/BUP/BZO/COC/MDMA/MET/OPI300/MTD/OXY/PCP/ |
Trademark Results [Tanner Scientific]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TANNER SCIENTIFIC 86239556 4628677 Live/Registered |
MERCEDES MEDICAL, LLC 2014-04-02 |
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