Identity
- Trade Name
- BARBITURATES LEVEL 1 FDA UDI
- Generic Name
- Barbiturate IVD, control FDA UDI
- Device Name
- BARBITURATES LEVEL 1 FDA UDI
- Model / Reference
- BARBS 1 U UPENN FDA UDI
- Description
- BARBITURATES LEVEL 1 FDA UDI
Identifiers
- Catalog Number
- BARBS 1 U UPENN FDA UDI
- Primary DI / UDI-DI
- B800BARBS1UUPENN0 FDA UDI
- FDA Product Code
- DIF FDA UDI
- GMDN Term
- Barbiturate IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3280 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Barbiturate IVD, control
Barbiturates Level 1 by Utak Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Barbiturate IVD, control.
- Barbiturate DAU Control, Control 4 — Lin-Zhi International, Inc. · Class I
- Pointe Barbiturate Control (Secobarbital 400 ng/mL) — POINTE SCIENTIFIC, INC. · Class I
- Barbiturate DAU Calibrator/Control, Calibrator #4/Cutoff B/Control 3 — Lin-Zhi International, Inc. · Class I
- Barbiturate DAU Calibrator/Control, Calibrator #2/Control 1 — Lin-Zhi International, Inc. · Class I
- Barbiturate DAU Calibrator/Control, Calibrator #3/Cutoff A/Control 2 — Lin-Zhi International, Inc. · Class I
- BARBITURATES 500 NG/ML — UTAK LABORATORIES, INC. · Class I
- BARBITURATES LEVEL 2 — UTAK LABORATORIES, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Utak Laboratories, Inc.
Sources (1)
- FDA UDI 80c8ab51-34ec-47a6-9892-b4583c7a5b4c 37 fields · synced Jun 8, 2026