DEVICE: ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin (05060242471063)

Device Identifier (DI) Information

ALBAlect Anti-A1 Dolichos biflorus Blood Grouping Lectin
Z241U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471063
GS1

1
516536641 *Terms of Use
For the in vitro detection and identification of human A1 red blood cellls
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Anti-A1 red blood cell grouping IVD, lectin Lectin molecules extracted from Dolichos biflorus, capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for group A1 [ABO004] red blood cell antigens, using an agglutination method.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KSI Lectins And Protectins
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

854261b4-5e1f-4af8-a6bb-afdc04ca0233
March 29, 2018
2
September 24, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441312920445
vittorio.borromeo@quotientbd.com
CLOSE