Identity
- Trade Name
- StatusFirst Mono controls FDA UDI
- Generic Name
- Epstein-Barr virus (EBV) heterophile antibody IVD, control FDA UDI
- Device Name
- StatusFirst Mono Pos/Neg controls (2 x 1 mL) FDA UDI
- Model / Reference
- BSP-402C-00 FDA UDI
- Description
- StatusFirst Mono Pos/Neg controls (2 x 1 mL) FDA UDI
Identifiers
- Catalog Number
- BSP-402C-00 FDA UDI
- Primary DI / UDI-DI
- 10743816001010 FDA UDI
- GMDN Term
- Epstein-Barr virus (EBV) heterophile antibody IVD, control FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Epstein-Barr virus (EBV) heterophile antibody IVD, control
StatusFirst Mono controls by Princeton Biomeditech Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epstein-Barr virus (EBV) heterophile antibody IVD, control.
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Princeton Biomeditech Corp.
Sources (1)
- FDA UDI 45b89de2-551f-48f4-bd4c-ddc13eb61d15 36 fields · synced May 31, 2026