Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent FDA UDI
- Device Name
- HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) FDA UDI
- Model / Reference
- A1C2-30 FDA UDI
- Description
- HEMOGLOBIN A1C REAGENT, (2x 30mL R1, 2x 9.5mL R2a, 2x 0.5mL R2b) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021767 FDA UDI
- 510(k) Number
- K031539 FDA UDI
- FDA Product Code
- LCP FDA UDI
- GMDN Term
- Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cryptosporidium parvum immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent.
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
- JAS Diagnostics — Drew Scientific , Ltd. · Class II
Cleared under the same submission
K031539 also covers:
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
- JAS Diagnostics — Drew Scientific , Ltd.
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- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drew Scientific , Ltd.
Sources (1)
- FDA UDI d5ecd8f4-f27d-4ca7-91c6-24546f2579e3 36 fields · synced May 30, 2026