Identity
- Trade Name
- Acrometrix BB NAT HIV-1 POS. CTRL FDA UDI
- Generic Name
- HIV1 nucleic acid IVD, control FDA UDI
- Model / Reference
- 963602 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884883005891 FDA UDI
- FDA Product Code
- MYZ FDA UDI
- GMDN Term
- HIV1 nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- 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
No
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: HIV1 nucleic acid IVD, control
Acrometrix BB NAT HIV-1 POS. CTRL by Microgenics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as HIV1 nucleic acid IVD, control.
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- Exact Diagnostics — Exact Diagnostics · Class I
- MAS HIV p24 Positive Control — Microgenics Corporation · 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
- Microgenics Corporation
Sources (1)
- FDA UDI 0d4a4991-bf8e-4571-9bc1-cf5bc1ef451c 33 fields · synced Jun 9, 2026