DEVICE: ALBAcyte Reagent RBCs for Reverse Grouping, Antibody Screen (untreated) (05060242471179)

Device Identifier (DI) Information

ALBAcyte Reagent RBCs for Reverse Grouping, Antibody Screen (untreated)
Z451U
In Commercial Distribution

ALBA BIOSCIENCE LTD
05060242471179
GS1

1
516536641 *Terms of Use
2-3% Reagent Red Blood Cells, ALBAcyte Antibody Screening Cells for tube techniques.
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
Reverse ABO grouping reagent red blood cell (A1/A2/B/AB/O) IVD, kit, agglutination A collection of specifically characterized reagent red blood cells that are supplied together and intended to be used in reverse ABO blood group testing of a clinical specimen using an agglutination method. Cells are selected due to their individual blood group specificities, which may include blood group antigens A1, A2, B, AB and/or O.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
No Product Codes
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

2e9940c8-921e-4be0-80d5-b0d32fc7dfd4
March 29, 2018
2
November 15, 2014
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

[?]
+441314456261
vittorio.borromeo@quotientbd.com
CLOSE