Fingerstick Sample Collection Kit
- Primary DI
- 00811877010395
- Brand
- Fingerstick Sample Collection Kit
- Company
- Alere Scarborough, Inc.
- Model
- 2604US199
- Device description
- Kit Intended to facilitate fingerstick whole blood sampling.
- Published
- 2022-01-13
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00811877010395 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00811877010395 | 00811877010395 | 811877010395 | 0811877010395 |
GMDN Terms#
| Term | Definition |
|---|---|
| HIV1/HIV2 antigen/antibody IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 154148498
- Device count
- 1
- Kit
- true
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10811877010064 | ISOSTAT® Consumables | 50C9 | 2016-09-05 | |
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| 10811877011245 | WOUNDCHEK™ Bacterial Status | 360006US | 2020-05-26 | |
| 00811877012153 | ID NOW Instrument | NAT-024R | 2025-08-01 | |
| 00811877011477 | BinaxNOW COVID-19 Antigen Self Test | 195-140 | 2023-09-05 | |
| 00811877011118 | BinaxNOW COVID-19 Antigen Self Test | 195-170 | 2023-08-11 | |
| 00811877011729 | BinaxNOW COVID-19 Antigen Self Test | 195-180 | 2022-10-03 | |
| 00811877011408 | BinaxNOW COVID-19 Antigen Self Test | 195-160 | 2021-04-21 | |
| 10811877010934 | Osteomark NTx Urine | 9006 | 2020-09-16 | |
| 10811877010941 | Osteomark NTx Serum | 9021 | 2020-09-16 | |
| 00811877010050 | ISOSTAT® Press and Rack | 50C2 | 2016-09-05 | |
| 00811877010098 | ISOSTAT® Containment Adapter | 50C1 | 2016-09-03 | |
| 00811877012030 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002050 | 2025-01-30 | |
| 00811877012047 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002056 | 2025-01-30 | |
| 00811877012054 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002051 | 2025-01-30 | |
| 00811877012061 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002057 | 2025-01-30 | |
| 00811877012078 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002052 | 2025-01-30 | |
| 00811877012085 | BinaxNOW COVID-19/Flu A&B Combo Self Test | 20002058 | 2025-01-30 | |
| 00811877012092 | BinaxNOW COVID-19/Flu A&B | 20002054 | 2025-01-30 |