Identity
- Trade Name
- Ansh Labs PECheck(TM) PAPP-A2 ELISA FDA UDI
- Generic Name
- Pregnancy-associated plasma protein-A2 (PAPP-A2) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The PECheckTM PAPP-A2 Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A2 in human maternal serum and other biological fluids. The kit is intended for in vitro diagnostic use. FDA UDI
- Model / Reference
- AL-1015-i FDA UDI
- Description
- The PECheckTM PAPP-A2 Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of PAPP-A2 in human maternal serum and other biological fluids. The kit is intended for in vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- AL-1015-i FDA UDI
- Primary DI / UDI-DI
- 00853592008356 FDA UDI
- GMDN Term
- Pregnancy-associated plasma protein-A2 (PAPP-A2) IVD, kit, enzyme immunoassay (EIA) 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pregnancy-associated plasma protein-A2 (PAPP-A2) IVD, kit, enzyme immunoassay (EIA)
Ansh Labs PECheck(TM) PAPP-A2 ELISA by Ansh Labs, LLC — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pregnancy-associated plasma protein-A2 (PAPP-A2) IVD, kit, enzyme immunoassay (EIA).
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
- Ansh Labs, LLC
Sources (1)
- FDA UDI 32101699-cb38-42dc-ab58-eee2a47f3e5d 35 fields · synced May 30, 2026