FDA UDI
In Commercial Distribution
🇺🇸 United States
RDS
DI: 10694644700012
·
Model: 10-RSV-060
·
AMERICAN BIO MEDICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- RDS
- Primary DI
- 10694644700012
- Version / Model
- 10-RSV-060
- Catalog Number
- 10-RSV-060
- Company Name
- AMERICAN BIO MEDICA CORPORATION
- Labeler DUNS
- 966665036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- d8660a05-8718-4500-bb22-dd8122cf4905
Device Description
RSV Test Kit US Version 135060
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | Microbiology | 866.3480 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48263 | Influenza virus/respiratory syncytial virus (RSV) antigen IVD, calibrator | A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antigens from influenza viruses (e.g., influenza A, influenza B) and respiratory syncytial virus (RSV) in a clinical specimen. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10694644700012 | GS1 | ||||
| Unit of Use | 10694644750017 | GS1 |
Customer Contacts
- Phone
- 518-758-8158
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K021789 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit