FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SPOTCHEM™ II LDH
DI: 00015482771201
·
Model: 77120
·
ARKRAY USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- SPOTCHEM™ II LDH
- Primary DI
- 00015482771201
- Version / Model
- 77120
- Company Name
- ARKRAY USA, INC.
- Labeler DUNS
- 008171162
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2024-05-31
- Public Version Status
- Update
- Public Device Record Key
- 2009f46e-0ee1-432b-84d8-fefc70ae9c3d
- Distribution End Date
- 2024-05-30
Device Description
Strip description for the invitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples
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 |
|---|---|---|---|---|
| CFH | TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE | Clinical Chemistry | 862.1440 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46795 | Magnesium (Mg2+) IVD, kit, spectrophotometry | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of magnesium (Mg2+) 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 | 00015482771201 | GS1 | ||||
| Unit of Use | 50015482771206 | GS1 |
Customer Contacts
- Phone
- +1(877)538-8872
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius