DEVICE: GS (00847865010658)

Device Identifier (DI) Information

GS
26217
Not in Commercial Distribution
26217
Bio-RAD Laboratories, Inc.
00847865010658
GS1
June 30, 2021
1
844766394 *Terms of Use
GS HIV Combo Ag/Ab EIA, 192 Tests
CLOSE

Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48445 HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from and antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MZF Test, Hiv Detection
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BP100064 0
BP100064 9
No 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
Device Size Text, specify: 192 Tests
CLOSE

Device Record Status

38230529-a24a-4474-ae1a-a41c908da4cf
July 29, 2021
6
August 22, 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

[?]
+1(800)224-6723
techsupport.ussd-redmond@bio-rad.com
CLOSE