FDA UDI
In Commercial Distribution
🇺🇸 United States
Pointe Scientific, Inc. GGT
DI: 00811727014740
·
Model: HG959-1400
·
Medtest Dx, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pointe Scientific, Inc. GGT
- Primary DI
- 00811727014740
- Version / Model
- HG959-1400
- Catalog Number
- HG959-1400
- Company Name
- Medtest Dx, Inc.
- Labeler DUNS
- 070371210
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2023-07-06
- Public Version Status
- Update
- Public Device Record Key
- e9145899-e96b-45d6-8041-a00ab32d23f7
Device Description
Gamma glutamyl transferase Reagent is for the quantitative kinetic determination of gamma glutamyl transferase (gGT) activity in serum on Hitachi analyzers. For in vitro diagnostic use only. 1 x 1L, 1 x 400ml
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JQB | Kinetic Method, Gamma-Glutamyl Transpeptidase | Clinical Chemistry | 862.1360 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53027 | Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of gamma glutamyltransferase (GGT) in a clinical specimen, using a spectrophotometry method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811727014740 | GS1 |
Customer Contacts
- Phone
- 800-445-9853
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973157 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius