Identity
- Trade Name
- JAS Diagnostics FDA UDI
- Generic Name
- Total bilirubin IVD, control FDA UDI
- Device Name
- TOTAL BILI LIQUID (2x 125mL R1, 1x 5mL Sodium Nitrite) FDA UDI
- Model / Reference
- TBN2-125 FDA UDI
- Description
- TOTAL BILI LIQUID (2x 125mL R1, 1x 5mL Sodium Nitrite) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817274021958 FDA UDI
- 510(k) Number
- K003829 FDA UDI
- FDA Product Code
- CIG FDA UDI
- GMDN Term
- Total bilirubin IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1110 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: Total bilirubin IVD, control
JAS Diagnostics by Drew Scientific , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total bilirubin IVD, control.
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- LIQUID BILIRUBIN CONTROL - LEVEL 2 (LIQ BIL CONTROL 2) — Randox Laboratories, Ltd. · Class I
- Audit MicroControls Linearity FD Bilirubin Beckman AU — Aalto Scientific, Ltd.
- Pediatric Bilirubin Control Level 1&2 Set 2x3mL — QUANTIMETRIX CORP. · Class I
- LIQUID FROZEN BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) — Randox Laboratories, Ltd. · Class I
- LIQUID BILIRUBIN CONTROL - LEVEL 1 (LIQ BIL CONTROL 1) — Randox Laboratories, Ltd. · Class I
Cleared under the same submission
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 71c98fd0-6c49-4e64-9519-743db0a9c31d 36 fields · synced May 30, 2026