FDA UDI
In Commercial Distribution
🇺🇸 United States
Immunalysis
DI: 00840937105108
·
Model: QS-0500
·
IMMUNALYSIS CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Immunalysis
- Primary DI
- 00840937105108
- Version / Model
- QS-0500
- Catalog Number
- QS-0500
- Company Name
- IMMUNALYSIS CORP
- Labeler DUNS
- 002804244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 8
- Public Version Date
- 2024-04-10
- Public Version Status
- Update
- Public Device Record Key
- 5e89d114-1a40-4aed-9184-e8445226ac59
Device Description
Quantisal Oral Fluid Collection Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| PJD | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61164 | Oral/upper respiratory tract specimen collection kit | A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840937105108 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius