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MedTest DX Elevated HCG Control Vial Label - B
FDA UDIClass I (US FDA UDI)
by Medtest DX
Identity
- Trade Name
- MedTest DX Elevated HCG Control Vial Label - B FDA UDI
- Generic Name
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
- Device Name
- Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL. FDA UDI
- Model / Reference
- HCGCTLB FDA UDI
- Description
- Elevated HCG Control Vial Label - B, For In Vitro Diagnostic Use. HCG Control is an unassayed, stable, ready to use liquid, bi-level control for use with assays designed to quantitate HCG. It is intended for determining “Hook-Dose Effect” and the accuracy and precision of dilution protocols. Size: 1 x 2.5 mL. FDA UDI
Identifiers
- Catalog Number
- HCGCTLB FDA UDI
- Primary DI / UDI-DI
- 00817439020840 FDA UDI
- 510(k) Number
- K921206 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control
MedTest DX Elevated HCG Control Vial Label - B by Medtest DX — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, control.
- HEMOSURE® — HEMOSURE INC.
- OSOM hCG Urine Ctrl Set — Sekisui Diagnostics, LLC · Class II
- HCG SERUM CONTROL KIT — Sekisui Diagnostics, LLC · Class I
- MedTest DX HCG Control Set — Medtest DX · Class I
- MedTest DX Elevated HCG Control Vial Label - A — Medtest DX · Class I
- MedTest DX HCG Control Set Level A — Medtest DX · Class I
- MedTest DX HCG Control Set Level B — Medtest DX · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtest DX
Sources (1)
- FDA UDI 07af08e1-51d5-4914-b693-04b78917464b 37 fields · synced May 31, 2026