FDA UDI
In Commercial Distribution
🇺🇸 United States
Tanner Scientific®
DI: 00850011007174
·
Model: TNR HCGCOMBO
·
MERCEDES MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Tanner Scientific®
- Primary DI
- 00850011007174
- Version / Model
- TNR HCGCOMBO
- Catalog Number
- TNR HCGCOMBO
- Company Name
- MERCEDES MEDICAL, LLC
- Labeler DUNS
- 834472680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-22
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- 52f62a54-7295-49ac-ab54-b50481a11af2
Device Description
Tanner Scientific CLIA waived;Human Chorionic gonadotropin; HCG Combo Cassette,Pregnancy Urine/Serum Combo 50BX
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | 862.1155 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 54212 | Total human chorionic gonadotropin IVD, reagent | A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total human chorionic gonadotropin (HCG), which includes a combination of intact HCG, nicked HCG, alpha-HCG subunits, and beta-HCG subunits, in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850011007174 | GS1 | ||||
| Package | 10850011007171 | GS1 | Inner Pack | 50 | In Commercial Distribution | |
| Package | 20850011007178 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 8003312716
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112101 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit