FDA UDI
In Commercial Distribution
🇺🇸 United States
Rickettsia IgG ELISA
DI: 00840239052971
·
Model: EIA-5297
·
DRG International Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rickettsia IgG ELISA
- Primary DI
- 00840239052971
- Version / Model
- EIA-5297
- Catalog Number
- EIA-5297
- Company Name
- DRG International Inc
- Labeler DUNS
- 075150847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 1
- Public Version Date
- 2021-06-15
- Public Version Status
- New
- Public Device Record Key
- a572d8b1-6007-47d1-a0f0-51d206eac674
Device Description
The Spotted Fever Group Rickettsia IgG ELISA is intended for the detection of human IgG class antibody to Spotted Fever Group Rickettsia, to be used as an aid in the diagnosis of human infection by these pathogens.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| LSQ | REAGENT, RICKETTSIA SEROLOGICAL | Microbiology | 866.3500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51285 | Multiple Rickettsia species (spotted fever group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to one or multiple species of the rickettsial bacteria associated with spotted fever in a clinical specimen, using an enzyme immunoassay (EIA) method. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840239052971 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius