| Primary Device ID | 20722355001665 |
| NIH Device Record Key | 0566f7ef-181d-47fa-830f-2cd257c72b14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Detector Strep A |
| Version Model Number | IST-501-OBC33 |
| Catalog Number | IDSTREP-25 |
| Company DUNS | 119214195 |
| Company Name | IMMUNOSTICS COMPANY, INC |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com | |
| Phone | +1(732)918-0770 |
| technical@immunostics.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10722355001668 [Primary] |
| GS1 | 20722355001665 [Package] Contains: 10722355001668 Package: Case of 10 [10 Units] In Commercial Distribution |
| GS1 | 30722355001662 [Package] Package: Carton of 40 [40 Units] In Commercial Distribution |
| GS1 | 80722355001667 [Unit of Use] |
| GTY | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2016-09-21 |
| 10722355001293 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001309 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001316 - Detector hCG | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001330 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001347 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001354 - Detector hCG Stick | 2023-07-06 For the qualitative detection of hCG in urine |
| 10722355001361 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |
| 10722355001378 - Detector hCG Combi | 2023-07-06 For the qualitative detection of hCG in serum or urine |